Archive for category tDCS/rTMS

[WEB PAGE] The Use of Noninvasive Brain Stimulation, Specifically Transcranial Direct Current Stimulation After Stroke

Motor impairment is a leading cause of disability after stroke. Approaches such as noninvasive brain stimulation are being investigated to attempt to increase effectiveness of stroke rehabilitation interventions. There are several types of noninvasive brain stimulation: repetitive transcranial magnetic stimulation, transcranial direct stimulation (tDCS), transcranial alternative current stimulation, and transcranial pulsed ultrasound to name a few. Of the types of noninvasive brain stimulation, repetitive transcranial magnetic stimulation and tDCS have been most extensively tested to modulate brain activity and potentially behavior. These two techniques have distinctive modes of action. Repetitive transcranial magnetic stimulation directly stimulates neurons in the brain and, given the appropriate conditions, leads to new action potentials. On the other hand, tDCS polarizes neuronal tissue including neurons and glia modulating ongoing firing patterns. There are also differences in cost, utility, and knowledge skill required to apply tDCS and repetitive transcranial magnetic stimulation. Transcranial direct stimulation is relatively inexpensive, easy to administer, portable, and may be applied while undergoing therapy, with lasting excitability changes detectable up to 90 minutes after administration. Repetitive transcranial magnetic stimulation equipment is bulkier, expensive, technically more challenging, and a patient’s head must remain still when treatment is being applied therefore needs to be administered before or after a session of rehabilitation. Because of these differences, tDCS has been more accessible and has rapidly grew as a potential tool to be used in neurorehabilitation to facilitate retraining of activities of daily living (ADL) capacity and possibly to improve restoration of neurological function after stroke.

There are three current stimulation approaches using tDCS to modulate corticomotor regions after stroke. In anodal stimulation mode, the anode electrode is placed over the lesioned brain area and a reference electrode is applied over the contralateral orbitofrontal cortex. Anodal tDCS is placed over the ipsilesional hemisphere to improve the responses of perilesional areas to training protocols. In cathodal stimulation, the cathode electrode is placed over the nonlesioned brain area and reference electrode over the contralateral (ipsilesional) orbitofrontal cortex. This approach has been predicated on the hypothesis that the nonstroke hemisphere will be inhibited by tDCS resulting in an increased activation of the ipsilesional hemisphere due to rebalancing of a presumably abnormal interhemispheric interaction. Although some studies have shown this approach to be beneficial, the causative role of interhemispheric interaction imbalance has been recently challenged and refuted.1 Thus, if cathodal stimulation approaches are beneficial, the behavioral effect cannot be explained by a presumed correction of abnormal interhemispheric connectivity. Finally, dual tDCS approach involves simultaneous application of the anode over the ipsilesional and the cathode over the contralesional side. Here again, the intended mechanism of action is to rebalance the presumably abnormal interhemispheric interaction.

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CLINICAL QUESTIONS ADDRESSED

What is the best tDCS type and electrical configuration? What are the effects of tDCS with rehabilitation program for upper limb recovery after stroke?

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RESEARCH FINDINGS OF tDCS

This short article discusses data obtained from a network meta-analysis of randomized controlled trials and a recent meta-analysis. The network meta-analysis included 12 randomized controlled trials including 284 participants examining the effect of tDCS on ADL function in the acute, subacute, and chronic phases after stroke.2 The meta-analysis included 9 studies with 371 participants in any stage after stroke.3

The network meta-analysis found evidence of a significant moderate effect in favor of cathodal tDCS without significant effects of dual tDCS, anodal tDCS, or sham tDCS. There was no difference in safety (as assessed by dropouts and adverse events) between sham tDCS, physical rehabilitation, cathodal tDCS, dual tDCS, and anodal tDCS. Elsner in a previous review of tDCS in 2016 found an effect on improving ADL, as well as function of the arm and lower limb, muscle strength, and cognition. Thus, the findings from the most recent meta-analysis indicating cathodal that tDCS improves ADL capacity are in line with previous meta-analyses. Of note, there was no evidence of an effect of either cathodal or other tDCS stimulation approaches on upper paretic limb impairment after stroke as measured by the Fugl-Meyer scale.

A meta-analysis that included participants in any stage after the stroke showed that tDCS in conjunction with multiple sessions of rehabilitation had no significant effect over delivering therapy alone for upper limb impairment and activity after stroke. This negative finding might be due to patient’s being in an acute, subacute, or chronic stage after stroke as well as variations in the type of therapy performed paired with tDCS (ie, conventional vs. constraint-induced movement therapy vs. robot protocol).

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RECOMMENDATIONS FOR PHYSIATRIC PRACTICE

There seems to be a modest effect supporting the use of tDCS as a co-adjuvant of rehabilitation interventions to improve ADLs after stroke. Cathodal tDCS seems to be the most promising approach, especially when applied early after the stroke. However, the evidence remains preliminary and does not warrant a widespread change in clinical rehabilitation practice at this time.

There is no evidence supporting the use of tDCS to improve motor impairment (as measured by the FMS) at this point.

Importantly, tDCS remains as a very safe intervention, with no differences in safety when real vs. control tDCS is applied.

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REFERENCES

1. Xu J, Branscheidt M, Schambra H, et al: Rethinking interhemispheric imbalance as a target for stroke neurorehabilitation. Ann Neurol 2019;85:502–13

2. Elsner B, Kwakkel G, Kugler J, et al: Transcranial direct current stimulation (tDCS) for improving capacity in activities and arm function after stroke: a network meta-analysis of randomised controlled trials. J Neuroeng Rehabil 2017;14:

3. Tedesco Triccas L, Burridge J, Hughes A, et al: Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: a review and meta-analysis. Clin Neurophysiol2016;127:946–55

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[ARTICLE] Searching for the optimal tDCS target for motor rehabilitation – Full Text

Abstract

Background

Transcranial direct current stimulation (tDCS) has been investigated over the years due to its short and also long-term effects on cortical excitability and neuroplasticity. Although its mechanisms to improve motor function are not fully understood, this technique has been suggested as an alternative therapeutic method for motor rehabilitation, especially those with motor function deficits. When applied to the primary motor cortex, tDCS has shown to improve motor function in healthy individuals, as well as in patients with neurological disorders. Based on its potential effects on motor recovery, identifying optimal targets for tDCS stimulation is essential to improve knowledge regarding neuromodulation as well as to advance the use of tDCS in clinical motor rehabilitation.

Methods and results

Therefore, this review discusses the existing evidence on the application of four different tDCS montages to promote and enhance motor rehabilitation: (1) anodal ipsilesional and cathodal contralesional primary motor cortex tDCS, (2) combination of central tDCS and peripheral electrical stimulation, (3) prefrontal tDCS montage and (4) cerebellar tDCS stimulation. Although there is a significant amount of data testing primary motor cortex tDCS for motor recovery, other targets and strategies have not been sufficiently tested. This review then presents the potential mechanisms and available evidence of these other tDCS strategies to promote motor recovery.

Conclusions

In spite of the large amount of data showing that tDCS is a promising adjuvant tool for motor rehabilitation, the diversity of parameters, associated with different characteristics of the clinical populations, has generated studies with heterogeneous methodologies and controversial results. The ideal montage for motor rehabilitation should be based on a patient-tailored approach that takes into account aspects related to the safety of the technique and the quality of the available evidence.

Introduction

Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation technique which delivers a constant electric current over the scalp to modulate cortical excitability [1,2,3]. Different montages of tDCS may induce diverse effects on brain networks, which are directly dependent on the electrodes positioning and polarity. While anodal tDCS is believed to enhance cortical excitability, cathodal tDCS diminishes the excitation of stimulated areas, and these electrodes montages define the polarity-specific effects of the stimulation [4,5,6]. Due to the effects of tDCS on modulating cortical excitability, especially when applied to the primary motor cortex [2], this method of brain stimulation has been intensively investigated for motor function improvement both in healthy subjects [78] and in various neurological pathologies [910]. Neurological conditions that may obtain benefits from the use of tDCS include Stroke [11,12,13,14], Parkinson’s disease [15], Multiple Sclerosis [1617], among others.

The mechanisms of action underlying the modulation of neuronal activity induced by tDCS are still not completely understood. However, studies have demonstrated that the electric current generated by tDCS interferes in the resting membrane potential of neuronal cells, which modulates spontaneous brain circuits activity [1,2,3]. Some studies have suggested that tDCS could have an effect on neuronal synapsis’ strength, altering the activity of NMDA and GABA receptors, thus triggering plasticity process, such as long-term potentiation (LTP) and long-term depression (LTD) [1819]. The long-term effects of tDCS are also thought to be associated to changes in protein synthesis and gene expression [2021]. Additionally, neuroimaging study showed blood flow changes following stimulation, which may be related to a direct effect of tDCS over blood flow, with an increase in oxygen supply on cortical areas and subsequent enhancement of neuronal excitability [22]. Given these mechanisms, tDCS seems to be a potential valuable tool to stimulate brain activity and plasticity following a brain damage.

The advantages of using tDCS include its low cost, ease of application, and safety. To date, there is no evidence of severe adverse events following tDCS in healthy individuals, as well as in patients with neurological conditions, such as stroke [2324]. Among the potential side effects presented after this type of stimulation, the most common ones consist of burn sensation, itching, transient skin irritation, tingling under the electrode, headache, and low intensity discomfort [25]. As serious and irreversible side effects have not been reported, tDCS is considered a relatively safe and tolerable strategy of non-invasive brain stimulation.

The modifications of physiological and clinical responses induced by tDCS are extremely variable, as this type of stimulation can induce both adaptive or maladaptive plastic changes, and a wide spectrum of tDCS parameters influence the effects of this technique. Electrodes combination, montage and shape can easily interfere in the enhancement or inhibition of cortical excitability [626]. Other parameters that may influence these outcomes include current intensity, current flow direction, skin preparation, and stimulation intervals [32728] . In addition, in clinical populations, the heterogeneity of the brain lesions can also influence the inconsistency in tDCS effects [29]. Despite the goal of tDCS of modulating cortical areas by using different parameters, some studies have showed that, by altering cortical excitability, the electrical field could reach subcortical structures, such as basal ganglia, due to brain connections between cortical and subcortical areas [30,31,32,33]. This potential effect on deeper brain structure has supported the broad investigation of tDCS in various disorders, even if the cortical region under stimulating electrode is not directly linked to the neurological condition being investigated. Indeed, the current variable and moderate effect sizes from clinical tDCS studies in stroke encourage researchers to test alternative targets to promote motor recovery in this condition.

In this review, we discuss evidence on the application of four different tDCS montages to promote and enhance motor rehabilitation: [1] anodal tDCS ipsilateral and cathodal tDCS bilateral, [2] combination of central and peripheral stimulation, [3] prefrontal montage and [4] cerebellar stimulation.[…]

 

Continue —> Searching for the optimal tDCS target for motor rehabilitation | Journal of NeuroEngineering and Rehabilitation | Full Text

figure1

Fig. 1 Motor cortex stimulation in a scenario where the left hemisphere was lesioned. Figure a Anodal stimulation of left primary motor cortex: anode over the left M1 and cathode over the right supraorbital region. Figure b Cathodal stimulation of right primary motor cortex: cathode over the right M1 and anode over the left supraorbital region. Figure c Bilateral stimulation: anode over the affected hemisphere (left) and cathode over the non-affected hemisphere (right)

 

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[Editorial] Introducing the thematic series on transcranial direct current stimulation (tDCS) for motor rehabilitation: on the way to optimal clinical use

Introduction

Transcranial direct current stimulation (tDCS) is a method of noninvasive brain stimulation that directs a constant low amplitude electric current through scalp electrodes. tDCS has been shown to modulate excitability in both cortical and subcortical brain areas [], with anodal tDCS leading to increased neuronal excitability and cathodal tDCS inversely leading to reduced neuronal excitability. tDCS can also modulate blood flow (i.e. oxygen supply to cortical and subcortical areas []) and neuronal synapsis strength [], triggering plasticity processes (i.e. long-term potentiation and long-term depression). There is growing interest in using tDCS as a low-cost, non-invasive brain stimulation option for a wide range of potential clinical applications. Advantages of tDCS over other methods of non-invasive brain stimulation include favorable safety and tolerability profiles and its portability and applicability.

The use of tDCS in motor rehabilitation for neurological diseases as well as in healthy ageing is a growing area of therapeutic use. Although the results of tDCS interventions for motor rehabilitation are still preliminary, they encourage further research to better understand its therapeutic utility and to inform optimal clinical use. Therefore, The Journal of NeuroEngineering and Rehabilitation (JNER. https://jneuroengrehab.biomedcentral.com/) is pleased to present the thematic series entitled “tDCS application for motor rehabilitation”.

The goal of this thematic series is to increase the awareness of academic and clinical communities to different potential applications of tDCS for motor rehabilitation. Experts in the field were invited to submit experimental or review studies. A call for papers was also announced to reach those interested in contributing to this thematic series. This collection of articles was thought to present the most recent advances in tDCS for motor rehabilitation, addressing topics such as theoretical, methodological, and practical approaches to be considered when designing tDCS-based rehabilitation. The targeted disorders include but are not limited to: stroke, Parkinson’s disease, Cerebral Palsy, cerebellar ataxia, trauma, Multiple Sclerosis.

tDCS – A promising clinical tool for motor rehabilitation

tDCS has been used in experimental and clinical neuroscience for the study of brain functions and treatment in a range of disorders of the central nervous system. Of particular interest to this thematic series, a growing body of evidence suggest that tDCS has potential to become a clinical tool for motor rehabilitation.

The existing tDCS protocols using well-defined montages, stimulus durations and intensities are safe and well tolerated by both healthy individuals and clinical populations. There are no reported indications of any serious adverse effects, such as damage of brain tissue or seizure induction, with the use of 1–2 mA protocols []. The most commonly reported adverse effects included redness, tingling and itching sensations under the electrodes, as well as headache []. Moreover, the overall adverse effect rates are similar between active and sham tDCS [], which suggests that the mild adverse effects are related to electrode positioning on the skin and not the stimulation itself.

As tDCS is portable, devices can easily be transported, which circumvents accessibility barriers to health care (i.e. tDCS can easily be moved into clinics or wards). It can be implemented in combination with other kinds of interventions, such as cognitive or physical training or exercise, with this pairing possibly leading to synergistic benefit []. Although accumulating evidence highlights potential benefits offered by tDCS for motor rehabilitation, further research is required for tDCS to become an approved clinical tool. The majority of existing clinical trials has involved a limited number of participants, which may imply underpowered analysis. Thus, large-scale studies are needed to overcome this major flaw.

Due to the potential for self- or caregiver-application, remotely supervised protocols have been developed and recently found feasible for those with motor impairment []. However, these studies employ highly structured protocols and rigorous criteria with real time supervision via teleconference, and do not support a “do-it-yourself” tDCS practice. Instead, the remotely supervised protocols can be used to facilitate the clinical trial designs that are necessary in order to advance tDCS towards therapeutic use.

Data on optimal protocols and predictors of response to tDCS are currently lacking in the literature. Future studies in this field should focus on determining the optimal stimulation parameters and predictors of response to tDCS in different clinical populations. It seems that one size does not fit all in tDCS. However, previous studies may be limited, as standard clinical assessments may miss subtle motor improvements. Future outcomes for determining the effectiveness of tDCS for motor rehabilitation need to be robust. Therefore, combining tDCS protocols with other validated mobile technologies to monitor motor performance, such as wearable inertial sensors or innovative Internet of Things devices, may provide important insight into effectiveness within clinic and beyond.

Despite the positive progression of research to clinical practice, there are still questions to be answered before tDCS can be extensively recommended for motor rehabilitation.

• What is the ideal intensity and duration of the session?

• How many sessions are required?

• What is the ideal interval between sessions?

• What about patients’ characteristics?

• Who will benefit from tDCS?

• Do specific demographic characteristics lead to greater benefits?

Final considerations

We hope the accepted papers will contribute meaningfully to the body of knowledge in the field of tDCS for motor rehabilitation and that they will motivate the development of further research. Additionally, we hope this thematic series will assist both researchers and clinical professionals in making decisions for the achievement of optimal benefits throughout tDCS.

References

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    Bolzoni F, Pettersson L-G, Jankowska E. Evidence for long-lasting subcortical facilitation by transcranial direct current stimulation in the cat. J Physiol [Internet]. 2013 [cited 2018 Nov 10];591:3381–3399. Available from: http://doi.wiley.com/10.1113/jphysiol.2012.244764.
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    Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol [Internet]. 2000 [cited 2018 Nov 10];527 Pt 3:633–639. Available from: http://www.ncbi.nlm.nih.gov/pubmed/10990547.
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    Zheng X, Alsop DC, Schlaug G. Effects of transcranial direct current stimulation (tDCS) on human regional cerebral blood flow. Neuroimage [Internet]. 2011 [cited 2019 Feb 14];58:26–33. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21703350.
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    Polanía R, Paulus W, Antal A, Nitsche MA. Introducing graph theory to track for neuroplastic alterations in the resting human brain: a transcranial direct current stimulation study. Neuroimage [Internet]. 2011 [cited 2019 Feb 14];54:2287–2296. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1053811910012875.
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    Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, et al. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol [Internet] 2016 [cited 2018 Nov 10];127:1031–1048. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26652115.
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    Moffa AH, Brunoni AR, Fregni F, Palm U, Padberg F, Blumberger DM, et al. Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data. J Affect Disord [Internet]. 2017 [cited 2018 Nov 10];221:1–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28623732.
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    Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, et al. Safety of transcranial direct current stimulation: evidence based update 2016. Brain Stimul [Internet] 2016 [cited 2018 Nov 10];9:641–661. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27372845.
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    Fertonani A, Ferrari C, Miniussi C. What do you feel if I apply transcranial electric stimulation? Safety, sensations and secondary induced effects. Clin Neurophysiol [Internet]. 2015 [cited 2018 Nov 10];126:2181–2188. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25922128.
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    Kaski D, Dominguez R, Allum J, Islam A, Bronstein A. Combining physical training with transcranial direct current stimulation to improve gait in Parkinson’s disease: a pilot randomized controlled study. Clin Rehabil [Internet]. 2014 [cited 2018 Nov 10];28:1115–24. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24849794.
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    Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, et al. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson’s disease: An open-label study. J Clin Neurosci [Internet]. 2018 [cited 2018 Nov 10];57:51–57. Available from: http://www.ncbi.nlm.nih.gov/pubmed/30193898.

via Introducing the thematic series on transcranial direct current stimulation (tDCS) for motor rehabilitation: on the way to optimal clinical use | SpringerLink

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[ARTICLE] A review of transcranial electrical stimulation methods in stroke rehabilitation – Full Text

 

Abstract

Transcranial electrical stimulation (TES) uses direct or alternating current to non-invasively stimulate the brain. Neuronal activity in the brain is modulated by the electrical field according to the polarity of the current being applied. TES includes transcranial direct current stimulation (tDCS), transcranial random noise stimulation, and transcranial alternating current stimulation (tACS). tDCS and tACS are the two non-invasive brain stimulation techniques that have been used alone or in combination with other rehabilitative therapies for the improvement of motor control in hemiparesis. Increasing research in these methods is being carried out to improvise on the existing technology because they have proven to exhibit a lasting effect, thereby contributing to brain plasticity and motor re-learning. Artificial stimulation of the lesioned or non-lesioned hemisphere induces participation of its cells when a movement is being performed. The devices are portable, stimulation is easy to deliver, and they are not known to cause any major side effects which are the foremost reasons for their trials in stroke rehabilitation. Recent research is focused on maximizing the outcome of stroke rehabilitation by combining them with other modalities. This review focuses on stimulation protocols, parameters, and the results obtained by these techniques and their combinations.

Key Message: Motor recovery and control poses a great challenge in stroke rehabilitation. Transcranial electrical stimulation methods look promising in this regard as they have been shown to augment long-term and short-term potentiation in the brain which may have a role in motor re-learning. This review discusses transcranial direct current stimulation and transcranial alternating current stimulation in stroke rehabilitation.

According to World Health Organization (WHO) statistics on 2016, cardiovascular diseases (CVD) are the foremost cause of death and adult disability worldwide.[1],[2] Stroke statistics in India show that the incidence of stroke was 435/100,000 population and only one in three stroke survivors are hospitalized and given further rehabilitation because treatment is expensive.[3]

Stroke survivors are faced with paralysis of one side of the body, that is, the side contra-lateral to the affected side in the brain. Rehabilitation aims at strengthening these muscles to prevent wastage and bring back function to the maximum possible extent. Taking the upper extremity into consideration, a combination of muscle over-activity (spastic muscle) in certain groups and weakening in other groups causes poor motor control leading to deformities and inability to reach, grasp, and release objects.

Various therapies such as splinting, stretching exercises, functional electrical stimulation (FES), and mirror therapy are being used to treat this condition, with varying degrees of success. In an ideal situation, the aim of stroke rehabilitation is to recover the paralyzed limb to an extent that it is functionally useful. In this context, recent research is being conducted in neuroplasticity or motor-relearning. Neuroplasticity refers to the brain being able to adapt to changes in response to its external environment and stimulation. TES and transcranial magnetic stimulation (TMS) are the non-invasive brain stimulation (NIBS) methods that invoke this type of re-learning.[4],[5]

NIBS methods include TMS and TES since they non-invasively stimulate the cortex. These methods are still under research for medical applications and were first introduced to treat psychiatric conditions such as insomnia, chronic anxiety, mild depression and post stroke aphasia.[6],[7],[8] Recently, tDCS has also been tried on normal individuals and was shown to improve cognition, working memory, and performance.[9],[10],[11] These methods are now gaining importance in stroke rehabilitation because they provide motor relearning probably through cortical reorganization, which occurs because the neural continuity between the brain and the periphery is intact.[12]

This article attempts to review the stimulation protocols used for TES by various research groups and the results obtained. The first section begins with an introduction to non-invasive methods of brain stimulation followed by a brief summary on the history that led to the use of TES for stroke rehabilitation. Later sections deal with tDCS and tACS. The section on tDCS is further subdivided into tDCS alone and tDCS with adjuvant therapy. The tables give a list of the studies that have been carried out for neurorehabilitation, although it is not meant to be an exhaustive list.[…]

Continue —> A review of transcranial electrical stimulation methods in stroke rehabilitation Solomons CD, Shanmugasundaram V Neurol India

Figure 1: Placement of electrodes for a-tDCS and c-tDCS

Figure 1: Placement of electrodes for a-tDCS and c-tDCS

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[OPINION ARTICLE] The Two-Fold Ethical Challenge in the Use of Neural Electrical Modulation – Full Text

  • Centro Universitario Internazionale, Arezzo, Italy

The use of electrical stimulation to influence biological functions and/or pathological processes in the body has been recently termed “electroceuticals.” The most commonly used techniques are “neural electroceuticals,” forms of electrical modulation of the brain that seem to represent the new frontier both to treat neurological and psychiatric diseases, when no other effective treatments are available, and to enhance cognitive functions (Kambouris et al., 2014Reardon, 2014;Miller and Matharu, 2017).

These types of medical interventions have given rise to a wide ethical debate (Pickersgill and Hogle, 2015Lavazza and Colzato, 2018Packer et al., 2018). Here I wish to introduce two new challenges bearing important moral implications, which require the careful consideration of the scientific and philosophical community. These challenges can be co-present and can be placed in the same framework of human augmentation and the willingness to go beyond one’s own physiological limits. However, it is possible to analytically distinguish them according to their initial conditions and their different scopes, as it will be explained.

The first challenge concerns a possible shift from a mainly therapeutic use of electroceuticals to a use aimed at enhancement. This potential shift is due to the fact that technology has now fulfilled a very ancient human aspiration, that of overcoming one’s limits and improving indefinitely. And the effect of this shift could be a segmentation of society between enhanced and non-enhanced individuals, something that goes against the essentially egalitarian project of modern thought (Rawls, 1999Mason, 2006).

The second challenge concerns the aging tendency and the demographic contraction that characterize European countries and Japan, and which may soon affect other economically developed countries (Lutz et al., 2008Długosz, 2011Murray et al., 2018). This trend, over time, will reduce the overall availability of cognitive skills and abilities in those populations, who will have to manage increasingly complex and diversified societies and environments. This mismatch between the needs arising from one’s life context and the available resources could push people to resort to electroceuticals as means of strengthening their cognitive abilities, opening up scenarios in which ethical evaluations will have a role to play. Below, I will address these two challenges, giving more space to the first.

Going Beyond One’s Limits

Ever since the Odyssey, humans have always desired to alter their minds in a controlled manner through a mix of substances and to go beyond the limits established by brain physiology (Koops et al., 2013). In recent decades, important steps have been taken in this direction, both with new molecules able to act on brain chemistry and with instruments capable of electrically modulating brain activity (Dresler et al., 2018). Scientific consensus on the cognitive enhancement potential of the so-called Non-Invasive Brain Stimulation (NIBS) is not yet unanimous (see Horvath et al., 2015 on one side; Price and Hamilton, 2015 on the other side), but it is undeniable that there is a great investment in research. A growing amount of research studies have produced at least some results in the field, even with different effects at an inter- and intra-individual level. For example, Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation that so far has been used on healthy subjects to enhance mathematical cognition, reading, memory, mood, learning, perception, decision making, creativity motivation, and moral reasoning (Chi and Snyder, 2012Callaway, 2013Meinzer et al., 2013Snowball et al., 2013Parkin et al., 2015). The use of NIBS is very often deemed effective by the public due to wide media coverage and Internet ads (Fitz and Reiner, 2015). However, the road to enhancement is now open and more relevant and consistent results may come both from more in-depth knowledge on the functioning of the nervous system and from more performing devices.

What are the consequences of a greater concentration of medical-scientific skills and resources in the field of cognitive neuroenhancement? Medicine is changing, suggests Harari (2016, ch 9), whose line of reasoning is useful here, even though he does not refer to electroceuticals. Somewhat oversimplifying, it can be said that the vocation of medicine, for most of its history, has been to treat the sick, to restore to a better condition those who saw their health deteriorate or were born with a congenital pathology or deficit. Classical Hippocratic medicine has then recently introduced the idea of disease prevention and the notion of combating the symptoms of aging (Bynum, 2008). This was a conceptual and clinical turning point, which has opened the door to the idea of improving the physical and cognitive status of healthy people, thus fulfilling the human aspiration I mentioned earlier, which had not yet been reflected in medical practice.

From an ethical point of view, caring for the sick—at least in principle—is an egalitarian project, because it envisions a level of health which each person can and should ideally reach, despite the limits of medical knowledge and of material resources. This project goes hand in hand with—and derives from—the social and political idea that Christianity and the Enlightenment have brought onto the Western world, according to which all human beings have equal dignity and rights and deserve the same treatment (despite the many exceptions due to material contingencies and the organization of life in society) (Hunt, 2007).

As Harari emphasizes, enhancing those in good health might instead be an elitist project, because it necessarily ignores universal levels of functioning or performance that are applicable to all (More and Vita-More, 2013). Every individual legitimately seeks to gain an advantage over others by exploiting the means made available by medical research to those who can pay for them. Once a certain level of enhancement has been achieved by the whole—or at least by the majority—of the population, the given technology will be available to everyone in terms of both diffusion and cost, and there will be demand for new and further forms of enhancement. These forms of enhancement will be sought by medical-scientific research within the dynamic that always pushes further the frontier of technical knowledge.

Harari’s prediction is that the poorest people in the next 50 years will have much better healthcare than today, whereas the health inequality measured in functioning and physical-cognitive performance might get much worse. Strong inequalities have always been present in the history of mankind, even when enhancement was not even contemplated as a possibility. However, for reasons related to technical progress, today there may be no shared interest in ensuring healthcare to the entire population according to the best current standards.

In the twentieth century many states had an interest in, and the possibility of, integrating the masses in the social fabric, also by universally extending the benefits of modern medicine. In fact, there was the need to have millions of soldiers in good health and well-looked after when injured, while the industry benefited from millions of workers in good physical conditions and able to work in factories for many consecutive hours. These were the years when mass hygiene facilities and vaccination campaigns were introduced, and several epidemics were eradicated (cf. Pinker, 2018).

New Potential Inequalities

The economic and military dynamics of the twenty-first century might be very different from the past. In the era of drones and remote or self-driving military vehicles, mass armies are no longer needed: what is needed are only a few selected super-experts in war technology (Scharre, 2018). The advent of robotics and the use of big data combined with evolving algorithms also make a large part of human work obsolete, so that production tasks can be performed by machines, leaving human beings in charge of more complex activities such as design and supervision (Ford, 2015).

These trends, of which we can already see some indications, could be accentuated and accelerated by the research on cognitive enhancement: the best performing individuals will be the ones to occupy positions of responsibility, as society will want to entrust the most important tasks to those with the best skills (Santoni de Sio et al., 2014). There are also scenarios that seem to come from a dystopian novel and, to the current state of knowledge, are certainly not realistic: such scenarios involve the emergence of superhumans with exceptional physical, emotional and intellectual abilities, which will stand out from the rest of the non-enhanced or less enhanced individuals, because the differences will become not only quantitative but also qualitative, leading to the creation of different groups distinguished by temperament and interests (Bess, 2015).

In fact, quantitative differences concern the increase of cognitive abilities, for example memory. Those who can access these forms of empowerment become high-performing people, who can succeed in the workplace and then improve their condition outperforming those who are not enhanced. Qualitative differences instead are brought on, for example, by genetic modifications thanks to recent techniques such as CRISPR-Cas9 (Lavazza, 2019a). In that case, genetically modified individuals could be different from non-modified individuals in the same way as adults and children or the most educated people and the illiterate ones are different. And social consequences would be predictably very relevant.

The equality project entailed by the material and moral progress of the world so far—which substantially amounts to defeating hunger, diseases and war—aims to guarantee decent living conditions for everyone, so that all people can equally pursue their own life project. Instead, the new goals aiming at overcoming our mortal and uncertain human condition, mainly thanks to technology, can hardly be within everyone’s reach and, on the contrary, will often be linked to a privileged condition reserved for a few.

There has certainly been an increase in do-it-yourself use of simple transcranial direct current stimulation (tDCS) devices (Fitz and Reiner, 2015). However, dealing with the use of other latest generation electroceuticals and future more sophisticated devices we will have to address the challenge outlined above. Should we consider prohibiting the use of certain forms of enhancement or should we pursue egalitarian policies, allowing everyone to access electroceuticals? (Lavazza, 2019b). A possible (but debatable) solution is to try to enhance the moral abilities of individuals, to ensure the prevalence of pro-social motives and a general growth of the well-being of individuals and of whole society (Persson and Savulescu, 2012). If this was not possible, one could explore a use of cognitive enhancement according to Rawls’s influential view that inequalities are acceptable if they benefit the whole society (Lavazza, 2016). In this sense, cognitively enhancing certain professional figures or public decision-makers will give them a benefit that others will not enjoy but will positively reverberate on the general functioning of society.

Mandatory Enhancement?

The second challenge concerning electroceuticals is intertwined with the first, while it has a different scope. The processes of scientific and technological innovation on a global scale, along with the phenomena of social complexification, are undergoing continuous acceleration, which will require a greater availability of cognitive skills to manage this complexity and the associated problems (for example, those related to climate change and to the reduction of natural resources). According to Rindermann (2018), however, cognitive abilities in the Western world could go down due to demographic trends. In many nations, fewer births and a longer life expectancy result in a decline in memory, processing speed, attention, creativity and, therefore, in the capacity for innovation. Furthermore, the most educated and cognitively most capable people normally make fewer children.

It is difficult to quantify the phenomenon, both because it is new and because it is still little studied. However, it is plausible to assume that general aging will cause a decrease in the overall cognitive abilities of society. First, there will be more people over the age of 65, while people under the age of 65 will decrease in number. And it is established that “the normal aging process is associated with declines in certain cognitive abilities, such as processing speed and some aspects of memory, language, visuospatial function, and executive functions” (Harada et al., 2013; cf. also Reichman et al., 2010Salthouse, 2012Fechner et al., 2019). Secondly, with the number of elderly people increasing, even if the incidence rate remains fixed, the overall percentage of people suffering from diseases that affect cognition will increase. In the United States today there are about 6 million people with dementia; according to some estimates (Alzheimer’s Association, 2019) the number will go up to 14 million in 2050, while the overall population will remain stable or grow slightly.

The idea of making enhancement (and cognitive improvement/rehabilitation for aged people) widespread and perhaps even mandatory also comes from arguments that underline how some emergencies cannot be faced with the cognitive and moral endowments that we have today (Lavazza and Reichlin, 2019). Persson and Savulescu (2012), for example, have stated that humans are ethically unfit to face the challenges of the present age. Their argument rests on the fact that today’s humankind is facing two kind of threats “generated by the existence of modern scientific technology: the threats of weapons of mass destruction, especially in the hands of terrorist groups, and of climate change and environmental degradation” (Persson and Savulescu, 2012: 1). According to the authors, humans are not morally equipped to address such global problems within a democratic system, especially when it comes to environmental problems. Consequently, cognitive enhancement, understood as the basis of moral betterment, could become the object of policies that make it strongly recommended, encouraged, or mandatory.

In this framework, the classic suggestion is to increase the educational programs that allow for the enhancement of cognitive abilities, which constitute human capital. Specifically, reference is often made to cognitive training programs such as the reasoning training proposed by Klauer and Phye (2008). But if neurocognitive enhancement proves to be safe and effective, it promises to be quicker and more easily administrable to a greater percentage of the population compared to traditional programs, since it does not require the conscious and prolonged effort of the subject. In the case of a real decline in the cognitive abilities of a society as a whole, neurocognitive intervention via neural electrical modulation would become one of the viable options in order to improve the condition of the elderly and compensate for the loss of their cognitive skills and to partially rehabilitate people with degenerative diseases.

This would bring about some ethical questions, as well as the pressure to promote and spread forms of enhancement, and improvement for aged people (since they can only regain the previous performance). In this case, those who want to occupy relevant roles in society might be asked or even forced to undergo the enhancement to make up for the general decline in cognitive abilities. Ethical reflection will then be called to clarify the obligations to be enhanced and the rights of those who do not want to alter the functioning of their mind / brain.

This situation does not exclude the tendency linked to the first challenge that I have illustrated. On the one hand, medicine is concentrating on enhancing a lucky few, who could take advantage of the current dynamics to reverse the pursuit of equality that our societies have been implementing for some time (apart from temporary fluctuations in the distribution of income and wealth). On the other hand, demographic decline and aging may require that more people resort to cognitive enhancement, improvement and rehabilitation to compensate for the decrease in the overall capabilities available to address the complex problems we are facing today.

Conclusion

These scenarios find their preconditions in trends that are already in place, but which will not be necessarily realized. However, they seem to deserve attention from all those working in the field of electroceuticals and from public decision-makers, that is, all those who can affect future situations. Philosophers and neuroethicists are entrusted with the task of thinking about these scenarios so as not to be unprepared in case they come true.

In the face of these challenges, however, some lines of intervention can already be hypothesized. Faced with the first challenge—that is, the possible shift from a mainly therapeutic use of electroceuticals to a use aimed at enhancement—a stricter regulation of devices must be promoted (Dubljević, 2015Maslen et al., 2015). Secondly, scientists and clinicians could try to establish guidelines for the use of electroceuticals that should consider not only the safety features but also the possible social consequences of a widespread use of these enhancement techniques. Thirdly, research should be directed primarily at clinical applications, before moving toward the enhancement of healthy subjects.

As for the second challenge, the three recommendations set out above apply as well. More specifically, all operators engaged in medical practices involving electroceuticals should refer to the ethical codes of their respective professions and to international conventions (for example the Oviedo Convention) for the protection of human rights and dignity. All these rules already in force prevent the mandatory administration of medical treatments, except in extraordinary cases that are, or should be, well-specified. It would therefore be important to avoid defining electroceuticals as a non-medical treatment in order to use them only within a legal framework.

Faced with political decisions that could go toward the violation of the rules in force, the scientific community would have the responsibility to highlight the potential risks involved and to actively prevent them as well.

References

[…]

 

Continue —>  Frontiers | The Two-Fold Ethical Challenge in the Use of Neural Electrical Modulation | Neuroscience

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[Abstract] Bi-cephalic transcranial direct current stimulation combined with functional electrical stimulation for upper-limb stroke rehabilitation: A double-blind randomized controlled trial

Highlights

Bi-cephalic transcranial direct current stimulation (tDCS) plus functional electrical stimulation (FES) slightly improves reaching motor performance after stroke.

Bi-cephalic tDCS plus FES does not enhance reaching movement quality after stroke.

Bi-cephalic tDCS plus FES improves handgrip strength after stroke.

Abstract

Background

Stroke survivors often present poor upper-limb (UL) motor performance and reduced movement quality during reaching tasks. Transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) are widely used strategies for stroke rehabilitation. However, the effects of combining these two therapies to rehabilitate individuals with moderate and severe impairment after stroke are still unknown.

Objective

Our primary aim was to evaluate the effects of concurrent bi-cephalic tDCS and FES on UL kinematic motor performance and movement quality. Our secondary aim was to verify the effects of the combined therapies on handgrip force and UL motor impairment.

Methods

We randomized 30 individuals with moderate and severe chronic hemiparesis after stroke into tDCS plus FES (n = 15) and sham tDCS plus FES (n = 15) groups. Participants were treated 5 times a week for 2 weeks. Kinematic UL motor performance (movement cycle time, velocity profile) and movement quality (smoothness, trunk contribution, joint angles), handgrip force and motor impairment were assessed before and after the intervention.

Results

For those participants allocated to the tDCS plus FES group, therapy was effective to improve movement cycle time (P = 0.039), mean reaching phase velocity (P = 0.022) and handgrip force (P = 0.034). Both groups showed improved mean returning phase velocity (P = 0.018), trunk contribution (P = 0.022), and movement smoothness (P = 0.001) as well as alleviated UL motor impairment (P = 0.002).

Conclusions

Concurrent bi-cephalic tDCS and FES slightly improved reaching motor performance and handgrip force of individuals with moderate and severe UL impairment after stroke.

via Bi-cephalic transcranial direct current stimulation combined with functional electrical stimulation for upper-limb stroke rehabilitation: A double-blind randomized controlled trial – ScienceDirect

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[ARTICLE] Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial – Full Text

Abstract

Background

Recovery of voluntary movement is a main rehabilitation goal. Efforts to identify effective upper limb (UL) interventions after stroke have been unsatisfactory. This study includes personalized impairment-based UL reaching training in virtual reality (VR) combined with non-invasive brain stimulation to enhance motor learning. The approach is guided by limiting reaching training to the angular zone in which active control is preserved (“active control zone”) after identification of a “spasticity zone”. Anodal transcranial direct current stimulation (a-tDCS) is used to facilitate activation of the affected hemisphere and enhance inter-hemispheric balance. The purpose of the study is to investigate the effectiveness of personalized reaching training, with and without a-tDCS, to increase the range of active elbow control and improve UL function.

Methods

This single-blind randomized controlled trial will take place at four academic rehabilitation centers in Canada, India and Israel. The intervention involves 10 days of personalized VR reaching training with both groups receiving the same intensity of treatment. Participants with sub-acute stroke aged 25 to 80 years with elbow spasticity will be randomized to one of three groups: personalized training (reaching within individually determined active control zones) with a-tDCS (group 1) or sham-tDCS (group 2), or non-personalized training (reaching regardless of active control zones) with a-tDCS (group 3). A baseline assessment will be performed at randomization and two follow-up assessments will occur at the end of the intervention and at 1 month post intervention. Main outcomes are elbow-flexor spatial threshold and ratio of spasticity zone to full elbow-extension range. Secondary outcomes include the Modified Ashworth Scale, Fugl-Meyer Assessment, Streamlined Wolf Motor Function Test and UL kinematics during a standardized reach-to-grasp task.

Discussion

This study will provide evidence on the effectiveness of personalized treatment on spasticity and UL motor ability and feasibility of using low-cost interventions in low-to-middle-income countries.

Background

Stroke is a leading cause of long-term disability. Up to 85% of patients with sub-acute stroke present chronic upper limb (UL) sensorimotor deficits [1]. While post-stroke UL recovery has been a major focus of attention, efforts to identify effective rehabilitation interventions have been unsatisfactory. This study focuses on the delivery of personalized impairment-based UL training combined with low-cost state-of-the-art technology (non-invasive brain stimulation and commercially available virtual reality, VR) to enhance motor learning, which is becoming more readily available worldwide.

A major impairment following stroke is spasticity, leading to difficulty in daily activities and reduced quality of life [2]. Studies have identified that spasticity relates to disordered motor control due to deficits in the ability of the central nervous system to regulate motoneuronal thresholds through segmental and descending systems [34]. In the healthy nervous system, the motoneuronal threshold is expressed as the “spatial threshold” (ST) or the specific muscle length/joint angle at which the stretch reflex and other proprioceptive reflexes begin to act [567]. The range of ST regulation in the intact system is defined by the task-specific ability to activate muscles anywhere within the biomechanical joint range of motion (ROM). However, to relax the muscle completely, ST has to be shifted outside of the biomechanical range [8].

After stroke, the ability to regulate STs is impaired [3] such that the upper angular limit of ST regulation occurs within the biomechanical range of the joint resulting in spasticity (spasticity zone). Thus, resistance to stretch of the relaxed muscle has a spatial aspect in that it occurs within the defined spasticity zone. In other joint ranges, spasticity is not present and normal reciprocal muscle activation can occur (active control zone; [4] Fig. 1). This theory-based intervention investigates whether recovery of voluntary movement is linked to recovery of ST control.[…]

Continue —> Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial | Trials | Full Text

Fig. 3Jintronix virtual reality (VR) games used in the intervention. a Fish Frenzy game requires the player to trace a three-dimensional (3D) trajectory by moving a fish on the screen in different shapes. b Kitchen Cleanup game requires forward reaching towards kitchen cutlery and returning them to shelves and drawers. c Garden Grab game requires lateral reaching while planting seeds, harvesting and transferring tomatoes to baskets. d Catch, Carry, Drop game requires bilateral coordination while catching apples, carrying and dropping them into a container

 

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[Abstract] Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial

Abstract

Background. Transcranial direct current stimulation (tDCS) has been suggested to improve poststroke recovery. However, its effects on bimanual motor learning after stroke have not previously been explored.

Objective. We investigated whether dual-tDCS of the primary motor cortex (M1), with cathodal and anodal tDCS applied over undamaged and damaged hemispheres, respectively, improves learning and retention of a new bimanual cooperative motor skill in stroke patients.

Method. Twenty-one chronic hemiparetic patients were recruited for a randomized, double-blinded, cross-over, sham-controlled trial. While receiving real or sham dual-tDCS, they trained on a bimanual cooperative task called CIRCUIT. Changes in performance were quantified via bimanual speed/accuracy trade-off (Bi-SAT) and bimanual coordination factor (Bi-Co) before, during, and 0, 30, and 60 minutes after dual-tDCS, as well as one week later to measure retention. A generalization test then followed, where patients were asked to complete a new CIRCUIT layout.

Results. The patients were able to learn and retain the bimanual cooperative skill. However, a general linear mixed model did not detect a significant difference in retention between the real and sham dual-tDCS conditions for either Bi-SAT or Bi-Co. Similarly, no difference in generalization was detected for Bi-SAT or Bi-Co.

Conclusion. The chronic hemiparetic stroke patients learned and retained the complex bimanual cooperative task and generalized the newly acquired skills to other tasks, indicating that bimanual CIRCUIT training is promising as a neurorehabilitation approach. However, bimanual motor skill learning was not enhanced by dual-tDCS in these patients.

via Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial – Maral Yeganeh Doost, Jean-Jacques Orban de Xivry, Benoît Herman, Léna Vanthournhout, Audrey Riga, Benoît Bihin, Jacques Jamart, Patrice Laloux, Jean-Marc Raymackers, Yves Vandermeeren, 2019

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[REVIEW] Strategies to implement and monitor in-home transcranial electrical stimulation in neurological and psychiatric patient populations: a systematic review – Full Text

Abstract

Background

Transcranial electrical stimulation is a promising technique to facilitate behavioural improvements in neurological and psychiatric populations. Recently there has been interest in remote delivery of stimulation within a participant’s home.

Objective

The purpose of this review is to identify strategies employed to implement and monitor in-home stimulation and identify whether these approaches are associated with protocol adherence, adverse events and patient perspectives.

Methods

MEDLINE, Embase Classic + Embase, Emcare and PsycINFO databases and clinical trial registries were searched to identify studies which reported primary data for any type of transcranial electrical stimulation applied as a home-based treatment.

Results

Nineteen published studies from unique trials and ten on-going trials were included. For published data, internal validity was assessed with the Cochrane risk of bias assessment tool with most studies exhibiting a high level of bias possibly reflecting the preliminary nature of current work. Several different strategies were employed to prepare the participant, deliver and monitor the in-home transcranial electrical stimulation. The use of real time videoconferencing to monitor in-home transcranial electrical stimulation appeared to be associated with higher levels of compliance with the stimulation protocol and greater participant satisfaction. There were no severe adverse events associated with in-home stimulation.

Conclusions

Delivery of transcranial electrical stimulation within a person’s home offers many potential benefits and appears acceptable and safe provided appropriate preparation and monitoring is provided. Future in-home transcranial electrical stimulation studies should use real-time videoconferencing as one of the approaches to facilitate delivery of this potentially beneficial treatment.

Introduction

Transcranial electrical stimulation (tES) is a technique used to modulate cortical function and human behaviour. It involves weak current passing through the scalp via surface electrodes to stimulate the underlying brain. A common type of tES is transcranial direct current stimulation (tDCS). Several studies have demonstrated tDCS is capable of modulating cortical function, depending on the direction of current flow [123]. When the anode is positioned over a cortical region, the current causes depolarisation of the neuronal cells, increasing spontaneous firing rates [4]. Conversely, positioning the cathode over the target cortical region causes hyperpolarisation and a decrease in spontaneous firing rates [4]. This modulation of cortical activity can be observed beyond the period of stimulation and is thought to be mediated by mechanisms which resemble long term potentiation and depression [5]. Along similar lines, transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are also forms of tES. Both tACS and tRNS are thought to interact with ongoing oscillatory cortical rhythms in a frequency dependent manner to influence human behaviour [678].

The ability of tES to selectively modulate cortical activity offers a promising tool to induce behavioural change. Indeed, several studies have demonstrated that tES may be a favourable approach to reduce impairment following stroke [9], improve symptoms of neglect [10], or reduce symptoms of depression [11]. While these results appear promising, there remains debate around technical aspects of stimulation along with individual participant characteristics that may influence the reliability of a stimulation response [1213141516171819202122]. However, current evidence does suggest that effects of stimulation may be cumulative, with greater behavioural improvements observed following repeated stimulation sessions [20]. Furthermore, tES has shown potential as a tool for maintenance stimulation, with potential relapses of depression managed by stimulation which continued over several months [2324]. Therefore, it may be that repeated stimulation sessions will become a hallmark of future clinical and research trials aiming to improve behavioural outcomes. This would require participants to attend frequent treatment sessions applied over a number of days, months or years. Given that many participants who are likely to benefit from stimulation are those with higher levels of motor or cognitive impairment, the requirement to travel regularly for treatment may present a barrier, limiting potential clinical utility or ability to recruit suitable research participants [25]. In addition, regular daily treatments would also hinder those who travel from remote destinations to receive this potentially beneficial neuromodulation. Therefore, there is a requirement to consider approaches to safely and effectively deliver stimulation away from the traditional locations of research departments or clinical facilities.

One benefit of tES over other forms of non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation, is the ability to easily transport the required equipment. This opportunity may allow for stimulation to be delivered in a participant’s home, which could represent the mode of delivery for future clinical applications. However, it may be unreasonable to expect that a participant would be capable of managing delivery of tES alone and would likely require some form of training and/or monitoring [25]. Although tES is considered relatively safe [26], stimulation should be delivered within established guidelines to avoid adverse events [27]. Inappropriate delivery of stimulation could result in neural damage, detrimental behavioural effects, irritation, burns or lesions of the skin [282930313233]. Therefore, in order to deliver stimulation safely to the appropriate cortical region, it is likely that in-home stimulation may require some form of monitoring [25].

It is currently unclear what the best approach is to implement and monitor in-home tES. An early paper proposed several guidelines to perform in home tES [34]. However, these guidelines were not based on evidence from published clinical trials as there were none available at the time of publication. One recent systematic review sought to discuss current work in this area and highlighted the need for further research to investigate safety, technical monitoring and assessment of efficacy [35]. Given the recent, and growing, interest in home-based brain stimulation, we felt it was now pertinent to conduct a review to specifically identify strategies employed to implement and monitor the use of in-home tES in neurological and psychiatric populations. The secondary questions were to report protocol adherence, adverse events and patient perspectives of in-home tES. Understanding optimal treatment fidelity for in-home brain stimulation will be instrumental to achieving higher levels of tES useability and acceptance within a participant’s home.[…]

 

via Strategies to implement and monitor in-home transcranial electrical stimulation in neurological and psychiatric patient populations: a systematic review | Journal of NeuroEngineering and Rehabilitation | Full Text

Fig. 2 Cochrane risk of bias tool was used to assess quality of included studies

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[NEWS] Brain stimulation improves depression symptoms, restores brain waves in clinical study — ScienceDaily

Date: March 11, 2019

Source: University of North Carolina Health Care

Summary: With a weak alternating electrical current sent through electrodes attached to the scalp, researchers successfully targeted a naturally occurring electrical pattern in a specific part of the brain and markedly improved depression symptoms in about 70 percent of participants in a clinical study.

FULL STORY

With a weak alternating electrical current sent through electrodes attached to the scalp, UNC School of Medicine researchers successfully targeted a naturally occurring electrical pattern in a specific part of the brain and markedly improved depression symptoms in about 70 percent of participants in a clinical study.

The research, published in Translational Psychiatry, lays the groundwork for larger research studies to use a specific kind of electrical brain stimulation called transcranial alternating current stimulation (tACS) to treat people diagnosed with major depression.

“We conducted a small study of 32 people because this sort of approach had never been done before,” said senior author Flavio Frohlich, PhD, associate professor of psychiatry and director of the Carolina Center for Neurostimulation. “Now that we’ve documented how this kind of tACS can reduce depression symptoms, we can fine tune our approach to help many people in a relatively inexpensive, noninvasive way.”

Frohlich, who joined the UNC School of Medicine in 2011, is a leading pioneer in this field who also published the first clinical trials of tACS in schizophrenia and chronic pain.

His tACS approach is unlike the more common brain stimulation technique called transcranial direct stimulation (tDCS), which sends a steady stream of weak electricity through electrodes attached to various parts of the brain. That approach has had mixed results in treating various conditions, including depression. Frohlich’s tACS paradigm is newer and has not been investigated as thoroughly as tDCS. Frohlich’s approach focuses on each individual’s specific alpha oscillations, which appear as waves between 8 and 12 Hertz on an electroencephalogram (EEG). The waves in this range rise in predominance when we close our eyes and daydream, meditate, or conjure ideas — essentially when our brains shut out sensory stimuli, such as what we see, feel, and hear.

Previous research showed that people with depression featured imbalanced alpha oscillations; the waves were overactive in the left frontal cortex. Frohlich thought his team could target these oscillations to bring them back in synch with the alpha oscillations in the right frontal cortex. And if Frohlich’s team could achieve that, then maybe depression symptoms would be decreased.

His lab recruited 32 people diagnosed with depression and surveyed each participant before the study, according to the Montgomery-Åsberg Depression Rating Scale (MADRS), a standard measure of depression.

The participants were then separated into three groups. One group received the sham placebo stimulation — a brief electrical stimulus to mimic the sensation at the beginning of a tACS session. A control group received a 40-Hertz tACS intervention, well outside the range that the researchers thought would affect alpha oscillations. A third group received the treatment intervention — a 10-Hertz tACS electrical current that targeted each individual’s naturally occurring alpha waves. Each person underwent their invention for 40 minutes on five consecutive days. None of the participants knew which group they were in, and neither did the researchers, making this a randomized double-blinded clinical study — the gold standard in biomedical research. Each participant took the MADRS immediately following the five-day regimen, at two weeks, and again at four weeks.

Prior to the study, Frohlich set the primary outcome at four weeks, meaning that the main goal of the study was to assess whether tACS could bring each individual’s alpha waves back into balance and decrease symptoms of depression four weeks after the five-day intervention. He set this primary outcome because scientific literature on the study of tDCS also used the four-week mark.

Frohlich’s team found that participants in the 10-Hertz tACS group featured a decrease in alpha oscillations in the left frontal cortex; they were brought back in synch with the right side of the frontal cortex. But the researchers did not find a statistically significant decrease in depression symptoms in the 10-Hertz tACS group, as opposed to the sham or control groups at four weeks.

But when Frohlich’s team looked at data from two weeks after treatment, they found that 70 percent of people in the treatment group reported at least a 50 percent reduction of depression symptoms, according to their MADRS scores. This response rate was significantly higher than the one for the two other control groups. A few of the participants had such dramatic decreases that Frohlich’s team is currently writing case-studies on them. Participants in the placebo and control groups experienced no such reduction in symptoms.

“It’s important to note that this is a first-of-its kind study,” Frohlich said. “When we started this research with computer simulations and preclinical studies, it was unclear if we would see an effect in people days after tACS treatment — let alone if tACS could become a treatment for psychiatric illnesses. It was unclear what would happen if we treated people several days in a row or what effect we might see weeks later. So, the fact that we’ve seen such positive results from this study gives me confidence our approach could help many people with depression.”

Frohlich’s lab is currently recruiting for two similar follow-up studies.

Other authors of the Translational Psychiatry paper are co-first authors Morgan Alexander, study coordinator and graduate student, and Sankaraleengam Alagapan, PhD, a postdoctoral fellow, both in the department of psychiatry at UNC-Chapel Hill; David Rubinow, MD, the Assad Meymandi Distinguished Professor and Chair of Psychiatry at the UNC School of Medicine; former UNC postdoctoral fellow Caroline Lustenberger, PhD; and Courtney Lugo and Juliann Mellin, both study coordinators at the UNC School of Medicine.

This research was funded through grants from the Brain Behavior Research Foundation, National Institutes of Health, the BRAIN Initiative, and the Foundation of Hope.

Frohlich holds joint appointments at UNC-Chapel Hill in the department of cell biology and physiology and the Joint UNC-NC State Department of Biomedical Engineering. He is also a member of the UNC Neuroscience Center.

Story Source:

Materials provided by University of North Carolina Health CareNote: Content may be edited for style and length.


Journal Reference:

  1. Morgan L. Alexander, Sankaraleengam Alagapan, Courtney E. Lugo, Juliann M. Mellin, Caroline Lustenberger, David R. Rubinow, Flavio Fröhlich. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD)Translational Psychiatry, 2019; 9 (1) DOI: 10.1038/s41398-019-0439-0

 

via Brain stimulation improves depression symptoms, restores brain waves in clinical study — ScienceDaily

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