Archive for category Spasticity

[Abstract] Effects of a 3D-printed orthosis compared to a low-temperature thermoplastic plate orthosis on wrist flexor spasticity in chronic hemiparetic stroke patients: a randomized controlled trial

The aim of this study was to compare the effects of two kinds of wrist-hand orthosis on wrist flexor spasticity in chronic stroke patients.

This is a randomized controlled trial.

The study was conducted in a rehabilitation center.

A total of 40 chronic hemiparetic stroke patients with wrist flexor spasticity were involved in the study.

Patients were randomly assigned to either an experimental group (conventional rehabilitation therapy + 3D-printed orthosis, 20 patients) or a control group (conventional rehabilitation therapy + low-temperature thermoplastic plate orthosis, 20 patients). The time of wearing orthosis was about 4–8 hours per day for six weeks.

Primary outcome measure: Modified Ashworth Scale was assessed three times (at baseline, three weeks, and six weeks). Secondary outcome measures: passive range of motion, Fugl-Meyer Assessment score, visual analogue scale score, and the swelling score were assessed twice (at baseline and six weeks). The subjective feeling score was assessed at six weeks.

No significant difference was found between the two groups in the change of Modified Ashworth Scale scores at three weeks (15% versus 25%, P = 0.496). At six weeks, the Modified Ashworth Scale scores (65% versus 30%, P = 0.02), passive range of wrist extension (P < 0.001), ulnar deviation (P = 0.028), Fugl-Meyer Assessment scores (P < 0.001), and swelling scores (P < 0.001) showed significant changes between the experimental group and the control group. No significant difference was found between the two groups in the change of visual analogue scale scores (P = 0.637) and the subjective feeling scores (P = 0.243).

3D-printed orthosis showed greater changes than low-temperature thermoplastic plate orthosis in reducing spasticity and swelling, improving motor function of the wrist and passive range of wrist extension for stroke patients.

via Effects of a 3D-printed orthosis compared to a low-temperature thermoplastic plate orthosis on wrist flexor spasticity in chronic hemiparetic stroke patients: a randomized controlled trial – Yanan Zheng, Gongliang Liu, Long Yu, Yanmin Wang, Yuan Fang, Yikang Shen, Xiuling Huang, Lei Qiao, Jianzhong Yang, Ying Zhang, Zikai Hua,

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[Abstract] Design of Powered Wearable Elbow Brace for Rehabilitation Applications at Clinic and Home – IEEE Conference Publication

Abstract

Spasticity and contractures are secondary to most neurological and orthopaedic pathologies. The most conservative method of management of spasticity and contractures is passive stretching exercises. Robotic rehabilitation aims to provide a solution to this problem. We describe in details the design of a powered wearable orthosis especially designed for managing spasticity and contractures. The device is fully portable, allowing the patient to undergo repeated-passive-dynamic exercises outside the hospital environment. The design of the device is modular to make it adaptable to different anatomies and pathologies. The device is also fitted with electrogoniometers and torque sensors to record kinematics and dynamics of the patient, improving the insight of the clinicians to the rehabilitation of the patient, as well as providing data for further clinical and scientific investigations. The mechanical integrity of the device elements is simulated and verified.

via Design of Powered Wearable Elbow Brace for Rehabilitation Applications at Clinic and Home – IEEE Conference Publication

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[NEWS] Botox is Now Approved for Lower-Limb Spasticity in Children

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The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox, Allergan) to ease lower-limb spasticity in children and adolescents aged 2 years to 17 years, excluding spasticity caused by cerebral palsy (CP), Allergan announces.

“Lower limb spasticity can impact many aspects of a child’s life and have a drastic influence on their overall development and quality of life,” David Nicholson, Allergan’s chief research and development officer, says in a news release.

The FDA approved Botox for lower-limb spasticity on the basis of safety and efficacy data from a phase 3 study involving more than 300 children aged 2 years or older with lower-limb spasticity.

Participants in the trial had CP, but the approved indication excludes lower-limb spasticity caused by CP, owing to marketing exclusivity by another company, according to Allergan.

The approved recommended dose per treatment session is 4 to 8 units/kg divided among affected muscles of the lower limb. The total dose for pediatric patients should not exceed 8 units/kg body weight, or 300 units, whichever is lower.

When treating both lower limbs or upper and lower limbs in combination, the total dose for pediatric patients should not exceed 10 units/kg, or 340 units, whichever is lower, in a 3-month interval, the company states.

“Pediatric lower limb spasticity inhibits normal muscular movement and function and can result in delayed or impaired motor development, as well as difficulty with posture and positioning,” Mark Gormley, Jr, MD, of Gillette Children’s Specialty Healthcare–St. Paul, comments, in the release.

“Botox has a well-established safety and efficacy profile, and supports children and adolescents successfully manage both their upper and lower limb spasticity,” said Gormley.

Botox was approved for pediatric upper-limb spasticity in June.

[Source: Medscape]

 

via Botox is Now Approved for Lower-Limb Spasticity in Children – Rehab Managment

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[BLOG POST] Home After a Stroke: What I Learned About Splints as a Stroke Survivor

What I Learned About Splints as a Stroke Survivor

When spasticity from a stroke holds muscles in one position, muscle fibers become short which restricts motion.  Lannin (1) concluded “splinting has little or no effect on the loss of range of motion” (p. 113).  Unfortunately, Lannin told therapists to stop all passive stretching and restrict active hand exercises to 10 minutes a day.  So the data does not tell us if a resting night splint is a useful addition to standard therapy.

I wondered what would happen if I continued to do passive stretching and active hand exercises, but stopped wearing my resting splint at night.  After a month of not wearing this splint I could feel my thumb getting tighter.  I resumed wearing my splint and the next morning I woke up with a wicked ache in my thumb.  My thumb is tight by bedtime so my splint has not eliminated spasticity.  Placing the hand in one static position does not retrain the brain to produce active range of motion (AROM).  Yet I believe my splint has prevented a painful permanent contracture.

I love my new SaeboStretch resting splint I wear at night.  The new soft straps do not cut into my skin the way the old plastic straps did.  This version also uses a new kind of “Velcro” that does not have spiky hooks that scratch my bare thigh.  Notice that there are now two finger straps and two thumb straps.  The cover zips off so it can be washed.

1.  Lannin N, Cusick A, McCluskey A, Herbert R. Effects of splinting on wrist contracture after stroke. Stroke. 2009;38:111-116.

 

via Home After a Stroke: What I Learned About Splints as a Stroke Survivor

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[WEB PAGE] Dysport is Now Approved for Upper Limb Spasticity as Well

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The United States Food and Drug Administration (FDA) has expanded the use of Dysport (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP), Ipsen Biopharmaceuticals, an affiliate of Ipsen, announces in a news release.

This approval makes Dysport the first botulinum toxin approved by the FDA for both pediatric spasticity indications, following the previous approval to treat children with lower limb spasticity aged two and older received in July 2016.

“For physicians, it is reassuring to have a botulinum toxin treatment in Dysport which demonstrated sustained symptom relief for spasticity, which can be physically challenging for children,” says Ann Tilton, MD, study investigator and Professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans, in the release.

“This FDA decision for Dysport means we now have an approved therapy to offer children and adolescents seeking improvements in mobility in both upper and lower limbs.”

The approval is based on a Phase 3 study with children aged two to 17 years old being treated for upper limb spasticity. Due to Orphan Drug Exclusivity, this approval excludes use in children with upper limb spasticity caused by CP. Dysport demonstrated statistically significant improvements from baseline at Week 6 with doses of 8 Units/kg and 16 Units/kg vs. 2 Units/kg, as measured by the Modified Ashworth Scale (MAS) in the elbow or wrist flexors.

Dysport demonstrated a reduction in spasticity symptoms through 12 weeks for most children for both upper and lower limbs. In the upper limb study, a majority of patients were retreated between 16-28 weeks; however, some patients had a longer duration of response (ie, 34 weeks or more). The most frequent adverse reactions observed were upper respiratory tract infection and pharyngitis, the release explains.

“This approval is a testament to Ipsen’s legacy in neurotoxin research and continued commitment to advancing patient care,” states Kimberly Baldwin, Vice President, Franchise Head, Neuroscience Business Unit, Ipsen. “We believe the data for both pediatric upper and lower limb spasticity underscore the role of Dysport as an important treatment option for patients seeking long-lasting spasticity symptom relief.”

For more information, visit Ipsen.

[Source(s): Ipsen, Business Wire]

 

via Dysport is Now Approved for Upper Limb Spasticity as Well – Rehab Managment

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[Abstract] Effects of kinesio taping on hemiplegic hand in patients with upper limb post-stroke spasticity: a randomized controlled pilot study

Abstract

BACKGROUND: Post-stroke spasticity is a common complication in patients with stroke and a key contributor to impaired hand function after stroke.
AIM: The purpose of this study was to investigate the effects of kinesio taping on managing spasticity of upper extremity and motor performance in patients with subacute stroke.
DESIGN: A randomized controlled pilot study.
SETTING: A hospital center.
POPULATION: Participants with stroke within six months.
METHODS: Thirty-one participants were enrolled. Patients were randomly allocated into kinesio taping (KT) group or control group. In KT group, Kinesio Tape was applied as an add-on treatment over the dorsal side of the affected hand during the intervention. Both groups received regular rehabilitation 5 days a week for 3 weeks. The primary outcome was muscle spasticity measured by modified Ashworth Scale (MAS). Secondary outcomes were functional performances of affected limb measured by using Fugl-Meyer assessment for upper extremity (FMA-UE), Brunnstrom stage, and the Simple Test for Evaluating Hand Function (STEF). Measures were taken before intervention, right after intervention (the third week) and two weeks later (the fifth week).
RESULTS: Within-group comparisons yielded significant differences in FMA-UE and Brunnstrom stages at the third and fifth week in the control group (P=0.003-0.019). In the KT group, significant differences were noted in FMA-UE, Brunnstrom stage, and MAS at the third and fifth week (P=0.001-0.035), and in the proximal part of FMA-UE between the third and fifth week (P=0.005). Between-group comparisons showed a significant difference in the distal part of FMA-UE at the fifth week (P=0.037).
CONCLUSIONS: Kinesio taping could provide some benefits in reducing spasticity and in improving motor performance on the affected hand in patients with subacute stroke.
CLINICAL REHABILITATION IMPACT: Kinesio taping could be a choice for clinical practitioners to use for effectively managing post-stroke spasticity.

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via Effects of kinesio taping on hemiplegic hand in patients with upper limb post-stroke spasticity: a randomized controlled pilot study – European Journal of Physical and Rehabilitation Medicine 2019 October;55(5):551-7 – Minerva Medica – Journals

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[BLOG POST] PathMaker Neurosystems – Publication of First Clinical Trial Results for MyoRegulator® Device for Non-Invasive Treatment of Spasticity

PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with spasticity and paralysis has announced the first publication of clinical trial results for its MyoRegulator® device for the non-invasive treatment of spasticity. Published in Bioelectronic Medicine, the results provide the first clinical evidence using MyoRegulator to treat upper extremity spasticity in subjects with chronic stroke. MyoRegulator is an investigational medical device and is limited by US Federal law to investigational use only.

Spasticity is a chronic condition characterised by painful muscle contractions and is common in patients suffering from stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological disorders. Management of spasticity is a difficult challenge and is currently managed primarily by pharmacological agents and injected botulinum neurotoxins, and there is tremendous unmet medical need.  MyoRegulator is a first-in-class non-invasive device based on PathMaker’s proprietary DoubleStim™ technology (combining anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS)), which provides simultaneous non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity.

“Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient,” said co-author Zaghloul Ahmed, Ph.D., Professor and Chairman, Department of Physical Therapy and Professor, Center for Developmental Neuroscience, CUNY and Scientific Founder of PathMaker Neurosystems. “The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”

The publication, Non-Invasive Treatment of Patients with Upper Extremity Spasticity Following Stroke Using Paired Trans-spinal and Peripheral Direct Current Stimulation, was authored by researchers at Feinstein Institute for Medical Research at Northwell Health (Manhasset, NY) led by Bruce Volpe, M.D. The study included patients with upper limb hemiparesis and wrist spasticity at least 6 months after their initial stroke in a single-blind, sham-controlled, crossover design study to test whether MyoRegulator treatment reduces chronic upper-extremity spasticity.

Twenty subjects received five consecutive 20-minute daily treatments with sham stimulation followed by a 1-week washout period, then five consecutive 20-minute daily treatments with active stimulation. Subjects were told that the order of active or sham stimulation would be randomized. Clinical and objective measures of spasticity and motor function were collected before the first session of each condition (baseline), immediately following the last session of each condition, and weekly for 5 weeks after the completion of active treatments. The results demonstrated significant group mean reductions from baseline in both Modified Tardieu Scale scores (summed across the upper limb, P<0.05), and in objectively measured muscle resistance at the wrist flexor (P<0.05) following active treatment as compared to following sham treatment. Motor function also improved significantly (measured by the Fugl-Meyer and Wolf Motor Function Test; P<0.05 for both tests) after active treatment, even without additional prescribed activity or training. The effect of the active MyoRegulator treatment was durable for the 5-week follow-up period.

We are highly encouraged by these clinical results which demonstrate the potential of MyoRegulator to improve outcomes for patients suffering from spasticity, without the need for surgery or drugs. Building on these results and our ongoing clinical trial in Europe, we expect to initiate a US multi-center, pivotal, double-blind clinical trial supported by the National Institute of Neurological Disorders and Stroke (NINDS) in early 2020.

Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker

 

About PathMaker Neurosystems Inc.

PathMaker Neurosystems is a clinical stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with chronic neuromotor conditions. With offices in Boston (US) and Paris (France), we are collaborating with world-class institutions to rapidly bring to market disruptive products for treating spasticity, paralysis and muscle weakness. In January 2019, we announced a collaboration and distribution agreement with WeHealth Digital Medicine to commercialise the MyoRegulator® device worldwide, excluding US and Japan territories retained by PathMaker.  More than 48 million patients in the US, Europe and China suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. At PathMaker, we are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions. For more information, please visit the company website at www.pmneuro.com.

Source: PathMaker Neurosystems Inc.

via PathMaker Neurosystems – Publication of First Clinical Trial Results for MyoRegulator® Device for Non-Invasive Treatment of Spasticity | ACNR | Online Neurology Journal

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[Abstract] Myoelectric Computer Interface Training for Reducing Co-Activation and Enhancing Arm Movement in Chronic Stroke Survivors: A Randomized Trial

Background. Abnormal muscle co-activation contributes to impairment after stroke. We developed a myoelectric computer interface (MyoCI) training paradigm to reduce abnormal co-activation. MyoCI provides intuitive feedback about muscle activation patterns, enabling decoupling of these muscles.

Objective. To investigate tolerability and effects of MyoCI training of 3 muscle pairs on arm motor recovery after stroke, including effects of training dose and isometric versus movement-based training.

Methods. We randomized chronic stroke survivors with moderate-to-severe arm impairment to 3 groups. Two groups tested different doses of isometric MyoCI (60 vs 90 minutes), and one group tested MyoCI without arm restraint (90 minutes), over 6 weeks. Primary outcome was arm impairment (Fugl-Meyer Assessment). Secondary outcomes included function, spasticity, and elbow range-of-motion at weeks 6 and 10.

Results. Over all 32 subjects, MyoCI training of 3 muscle pairs significantly reduced impairment (Fugl-Meyer Assessment) by 3.3 ± 0.6 and 3.1 ± 0.7 (P < 10−4) at weeks 6 and 10, respectively. Each group improved significantly from baseline; no significant differences were seen between groups. Participants’ lab-based and home-based function also improved at weeks 6 and 10 (P ≤ .01). Spasticity also decreased over all subjects, and elbow range-of-motion improved. Both moderately and severely impaired patients showed significant improvement. No participants had training-related adverse events. MyoCI reduced abnormal co-activation, which appeared to transfer to reaching in the movement group.

Conclusions. MyoCI is a well-tolerated, novel rehabilitation tool that enables stroke survivors to reduce abnormal co-activation. It may reduce impairment and spasticity and improve arm function, even in severely impaired patients.

 

via Myoelectric Computer Interface Training for Reducing Co-Activation and Enhancing Arm Movement in Chronic Stroke Survivors: A Randomized Trial – Emily M. Mugler, Goran Tomic, Aparna Singh, Saad Hameed, Eric W. Lindberg, Jon Gaide, Murad Alqadi, Elizabeth Robinson, Katherine Dalzotto, Camila Limoli, Tyler Jacobson, Jungwha Lee, Marc W. Slutzky, 2019

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[WEB SITE] About Mollii – Mollii

What is Mollii?


Mollii is a suit consisting of a pair of trousers, a jacket and a detachable control unit. The Mollii garments includes 58 imbedded electrodes, positioned to stimulate 40 key muscles in the body. Through a low frequency electro-stimulation therapy, Mollii relaxes spastic, tense and aching muscles safely and simply. Programmed after each person’s needs, Mollii prevents and counteracts different forms of muscle shortening and rigidity, helps the user regain control over muscular tension, and reduces pain related to spasticity. In addition, through electro-stimulation settings, Mollii may facilitate the activation of muscles, and thereby may facilitate muscle contractions, which in turn enable movements.

Who uses Mollii?


MG_8180_Svart_OK-1024x683Mollii is used by people who suffer from spasticity and spasticity-related pain, which is typically found in people with cerebral palsy, stroke, multiple sclerosis, spinal cord injury, acquired brain damages and other neurological injuries that result from or create motor disabilities, and generally induce pain. Mollii is used both by adults and children; and is available in men and women sizes starting from 104 cm. up to XXXL.

Mollii can be used in both a home and clinic environment; and is simple to use for all ages. Users dress-up with a Mollii the same way they would with an ordinary garment. There is a button for on/off and a button for play/ pause. A single push of the button starts the muscle stimulation, which proceeds automatically for 60 minutes, and has a lasting positive effect for up to 48 hours.”

How does it work?


Mollii stimulates the antagonist to the spastic muscle. If the bicep is spastic, the tricep is stimulated, which in turn makes the bicep relaxed. Relaxing the muscle enables active movements and a gradual improvement in function, while the body keeps this positive effect for up to 48 hours. The physiological mechanism is called reciprocal inhibition.

Mollii also reduces pain related to spasticity, both through the reciprocal inhibition, and via the gate control theory of pain, which asserts that non-painful input such as the electric stimulation of skin-nerves closes the nerve-gates to painful input, which prevents pain sensation from traveling to the central nervous system.

Moreover, Mollii may facilitate the sub-threshold stimulation of a muscle by preparing the muscle for contraction before generating a shortening of the muscle, thereby reducing the nerve signal-strength required by the patient to actually generate a muscle contraction.

It is a safe and simple assistive device that can increase quality of life and help recover faster motor functions. The device is used for one hour every second day. For optimum effect, Mollii should be used together with physiotherapy, training, activity and movement. The positive effect is individual and remains for up to 48 hours.

Want more information?


Mollii Product Sheet

Frequently asked questions

Who is Mollii for? Mollii is an assistive device for people with spasticity and other forms of motor impairment due to cerebral palsy, stroke, brain damage, spinal cord injury or other neurological injuries. Molli can also be used to alleviate spasticity related pain.
How does the Mollii suit work? Molli is a functional garment that consists of a pair of trousers, a jacket and a detachable control unit which sends electrical signals to the user via electrodes on the inside of the garment. The suit has 58 electrodes which can be combined in various ways. Mollii has a control unit which is individually programmed for each user. The person prescribing Mollii uses a computer program to adapt the active electrodes and the intensity (which muscles are to be activated by means of current). The settings are then saved in the Mollii control unit, making it simple for the device to be used at home.
What happens in the body when Mollii is used? Mollii uses low level electric current to produce basic tension in the musculature. The current stimulates the antagonist to the spastic muscle. If, for example, the biceps is spastic, the triceps is stimulated which in turn makes the biceps relax. Relaxing the muscle enables active movement and a gradual improvement in function. The physiological mechanism is called reciprocal inhibition.
What sizes are available for the Mollii suit? Available in 24 sizes for children from size CL 104 to ladies and mens sizes. Children (CL): 104, 110, 116, 122, 128, 134, 140, 146, 152 Ladies: XS, S, M, L, XL, XXL, XXXL, SXL Mens: XS, S, M, L, XL, XXL, XXXL
Is the Mollii suit User-friendly? Mollii is a functional assistive device that is designed to be used in the home environment. It is simple to use. If a person can put on an ordinary garment him/herself, then he/she can put Mollii on him/herself. There is a button for on/off and a button for play/ pause. A single push of the button starts muscle stimulation, which proceeds automatically for 60 minutes. The device is used for one hour every second day.
How often should the Mollii suit be used? The device is used for approximately one hour on 3-4 occasions per week. For optimum effect, Mollii should be used together with physiotherapy, training, activity and movement. The effect is individual and remains for up to 48 hours.
Mollii suit Safety Mollii is not to be used with electrical implanted devices or medical devices that are affected by magnets, such as shunts. Consult a doctor at: cardiovascular disease, malignancy (cancer), infectious disease, fever, pregnancy, rashes or skin problems and if Mollii is intended for use with other medical devices or other medical treatment. The product is to be used according to the user manual.
What is included with the mollii suit Supplied with: Jacket, trousers, control unit (with bag), belt, laundry bag and user manual.
Mollii suit Washing instructions 40 degrees delicate wash once per month. In between the garment can be hand washed in lukewarm water.
10 Mollii Technical information Power supply: 4 batteries (AAA) Voltage: 20 V Pulse width: 25-175 us Frequency: 20 Hz Pulse apperance: Square wave Channels: 40 Electrodes: 58 Electrode material: Silicone rubber Fabric material: Nylon 82 %, Spandex 18 %

via About Mollii – Mollii

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[WEB PAGE] Results from MyoRegulator for Spasticity Trial Published

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Results from a clinical trial testing the MyoRegulator device for the non-invasive treatment of spasticity, published recently in Bioelectronic Medicine, suggest evidence for using MyoRegulator to treat upper extremity spasticity in subjects with chronic stroke, PathMaker Neurosystems Inc announces.

PathMaker Neurosystems Inc is a clinical-stage bioelectronic medicine company that develops non-invasive systems for the treatment of patients with spasticity and paralysis. The MyoRegulator is an investigational medical device and is limited by US Federal law to investigational use only.

The device is based on PathMaker’s proprietary DoubleStim technology (combining anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS)), which provides simultaneous non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity, the company explains in a media release.

“Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient,” said co-author Zaghloul Ahmed, PhD, professor and chairman, Department of Physical Therapy and Professor, Center for Developmental Neuroscience, CUNY and Scientific Founder of PathMaker Neurosystems.

“The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”

The single-blind, sham-controlled, crossover design study, authored by researchers at Feinstein Institute for Medical Research at Northwell Health (and led by Bruce Volpe, MD, included patients with upper limb hemiparesis and wrist spasticity at least 6 months after their initial stroke to test whether MyoRegulator treatment reduces chronic upper-extremity spasticity.

Twenty subjects received five consecutive 20-minute daily treatments with sham stimulation followed by a 1-week washout period, then five consecutive 20-minute daily treatments with active stimulation. Subjects were told that the order of active or sham stimulation would be randomized.

Clinical and objective measures of spasticity and motor function were collected before the first session of each condition (baseline), immediately following the last session of each condition, and weekly for 5 weeks after the completion of active treatments.

The results demonstrated significant group mean reductions from baseline in both Modified Tardieu Scale scores (summed across the upper limb, P<0.05), and in objectively measured muscle resistance at the wrist flexor (P<0.05) following active treatment as compared to following sham treatment.

Motor function also improved significantly (measured by the Fugl-Meyer and Wolf Motor Function Test; P<0.05 for both tests) after active treatment, even without additional prescribed activity or training. The effect of the active MyoRegulator treatment was durable for the 5-week follow-up period, the release continues.

“We are highly encouraged by these clinical results which demonstrate the potential of MyoRegulator to improve outcomes for patients suffering from spasticity, without the need for surgery or drugs,” says Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker.

“Building on these results and our ongoing clinical trial in Europe, we expect to initiate a US multi-center, pivotal, double-blind clinical trial supported by the National Institute of Neurological Disorders and Stroke (NINDS) in early 2020.”

[Source: PathMaker Neurosystems Inc]

 

via Results from MyoRegulator for Spasticity Trial Published – Rehab Managment

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