Posts Tagged Safety

[Abstract] Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review – Epilepsy & Behavior

Highlights

We reviewed the crude risk of seizures and other adverse events of rTMS in patients with epilepsy.

A crude per-subject risk of 2.9% (95% CI: 1.3–4.5) was estimated for seizures occurring during or shortly after.

The safety of rTMS applied to patients with epilepsy appears to be the same as in other conditions.

Abstract

Approximately one-third of patients with epilepsy remain with pharmacologically intractable seizures. An emerging therapeutic modality for seizure suppression is repetitive transcranial magnetic stimulation (rTMS). Despite being considered a safe technique, rTMS carries the risk of inducing seizures, among other milder adverse events, and thus, its safety in the population with epilepsy should be continuously assessed.

We performed an updated systematic review on the safety and tolerability of rTMS in patients with epilepsy, similar to a previous report published in 2007 (Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007; 10 (4): 521–8), and estimated the risk of seizures and other adverse events during or shortly after rTMS application.

We searched the literature for reports of rTMS being applied on patients with epilepsy, with no time or language restrictions, and obtained studies published from January 1990 to August 2015. A total of 46 publications were identified, of which 16 were new studies published after the previous safety review of 2007.

We noted the total number of subjects with epilepsy undergoing rTMS, medication usage, incidence of adverse events, and rTMS protocol parameters: frequency, intensity, total number of stimuli, train duration, intertrain intervals, coil type, and stimulation site.

Our main data analysis included separate calculations for crude per subject risk of seizure and other adverse events, as well as risk per 1000 stimuli. We also performed an exploratory, secondary analysis on the risk of seizure and other adverse events according to the type of coil used (figure-of-8 or circular), stimulation frequency (≤1 Hz or >1 Hz), pulse intensity in terms of motor threshold (<100% or ≥100%), and number of stimuli per session (<500 or ≥ 500).

Presence or absence of adverse events was reported in 40 studies (n = 426 subjects). A total of 78 (18.3%) subjects reported adverse events, of which 85% were mild. Headache or dizziness was the most common one, occurring in 8.9%. We found a crude per subject seizure risk of 2.9% (95% CI: 1.3–4.5), given that 12 subjects reported seizures out of 410 subjects included in the analysis after data of patients with epilepsia partialis continua or status epilepticus were excluded from the estimate.

Only one of the reported seizures was considered atypical in terms of the clinical characteristics of the patients’ baseline seizures. The atypical seizure happened during high-frequency rTMS with maximum stimulator output for speech arrest, clinically arising from the region of stimulation. Although we estimated a larger crude per subject seizure risk compared with the previous safety review, the corresponding confidence intervals contained both risks. Furthermore, the exclusive case of atypical seizure was the same as reported in the previous report. We conclude that the risk of seizure induction in patients with epilepsy undergoing rTMS is small and that the risk of other adverse events is similar to that of rTMS applied to other conditions and to healthy subjects.

Our results should be interpreted with caution, given the need for adjusted analysis controlling for potential confounders, such as baseline seizure frequency. The similarity between the safety profiles of rTMS applied to the population with epilepsy and to individuals without epilepsy supports further investigation of rTMS as a therapy for seizure suppression.

Source: Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review – Epilepsy & Behavior

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[ARTICLE] Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy

Highlights

  • This study focused on technologies, safety and efficacy of exergames for older adults
  • Exergames show good potential as an exercise or rehabilitation tool for older adults
  • Based on the review, recommendations for practice and further research are provided
  • Exergames need to be personalized, safe and address multiple physical functions
  • Future studies should include longer follow-up, social aspects and game adherence

Abstract

Background: There has been a rapid increase in research on the use of virtual reality (VR) and gaming technology as a complementary tool in exercise and rehabilitation in the elderly population. Although a few recent studies have evaluated their efficacy, there is currently no in-depth description and discussion of different game technologies, physical functions targeted, and safety issues related to older adults playing exergames.

Objectives: This integrative review provides an overview of the technologies and games used, progression, safety measurements and associated adverse events, adherence to exergaming, outcome measures used, and their effect on physical function. Methods: We undertook systematic searches of SCOPUS and PubMed databases. Key search terms included “game”, “exercise”, and “aged”, and were adapted to each database. To be included, studies had to involve older adults aged 65 years or above, have a pre-post training or intervention design, include ICT-implemented games with weight-bearing exercises, and have outcome measures that included physical activity variables and/or clinical tests of physical function.

Results: Sixty studies fulfilled the inclusion criteria. The studies had a broad range of aims and intervention designs and mostly focused on community-dwelling healthy older adults. The majority of the studies used commercially available gaming technologies that targeted a number of different physical functions. Most studies reported that they had used some form of safety measure during intervention. None of the studies reported serious adverse events. However, only 21 studies (35%) reported on whether adverse events occurred. Twenty-four studies reported on adherence, but only seven studies (12%) compared adherence to exergaming with other forms of exercise. Clinical measures of balance were the most frequently used outcome measures. PEDro scores indicated that most studies had several methodological problems, with only 4 studies fulfilling 6 or more criteria out of 10. Several studies found positive effects of exergaming on balance and gait, while none reported negative effects.

Conclusion: Exergames show promise as an intervention to improve physical function in older adults, with few reported adverse events. As there is large variability between studies in terms of intervention protocols and outcome measures, as well as several methodological limitations, recommendations for both practice and further research are provided in order to successfully establish exergames as an exercise and rehabilitation tool for older adults.

Source: Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy

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[ARTICLE] Transcranial magnetic stimulation: A potential new treatment for depression associated with traumatic brain injury

Abstract

Background: Each year, more than 1.7 million Americans suffer a traumatic brain injury (TBI) and the lifetime prevalence of major depressive disorder following TBI is between 25–50%. There are no validated established strategies to treat TBI depression. Repetitive transcranial magnetic stimulation (rTMS) is a novel putative treatment option for post-TBI depression, which, compared with standard pharmacological agents, may provide a more targeted treatment with fewer side-effects. However, TBI is associated with an increased risk of both early and late spontaneous seizures, a significant consideration in evaluating rTMS as a potential treatment for TBI depression. Whilst the risk of seizure from rTMS is low, underlying neuropathology may somewhat increase that risk.

Review: This review focuses on the safety aspects of rTMS in TBI patients. The authors review why low frequency rTMS might be less likely to trigger a seizure than high frequency rTMS and propose low frequency rTMS as a safer option in TBI patients. Because there is little data on the safety of rTMS in TBI, the authors also review the safety of rTMS in patients with other brain pathology.

Conclusion: It is concluded that pilot safety and tolerability studies should be first conducted in persons with TBI and neuropsychiatric comorbidities. These results could be used to help design larger randomized controlled trials.

via Transcranial magnetic stimulation: A potential new treatment for depression associated with traumatic brain injury, Brain Injury, Informa Healthcare.

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[ARTICLE] What Do We Really Know About the Safety of Tai Chi?:

…TC is unlikely to result in serious AEs, but it may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of TC…

http://www.archives-pmr.org/article/S0003-9993(14)00392-X/abstract?rss=yes

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