Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke

2019-10-09 09:21:42 | BioPortfolio


The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investigational device (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) are able to improve wrist stiffness and motor function, when combined with intensive robotic wrist training program in participants with chronic spastic hemiparesis after stroke.


Stroke is the fifth leading cause of death and the leading cause of serious long-term disability in the U.S. Post-stroke impairment often presents as weakness of the upper and lower limbs and spasticity (muscle and joint stiffness and hyperactivity). This condition impacts motor recovery and renders the individual dependent for most activities of daily living. Even with aggressive standard rehabilitation, 65 percent of patients cannot incorporate their affected hand in functional activities six months after stroke. Investigators have previously demonstrated that robotic therapy provides significant benefits to upper limb motor recovery after stroke. The treatment has been acknowledged by the American Heart Association as an effective form of stroke rehabilitation.

Neuromodulation techniques such as noninvasive brain, nerve and spinal direct current stimulation have been proposed as promising safe tools for augmenting motor learning and function after brain injury. Ahmed (2014) demonstrated in a pre-clinical mouse model that the use of combined trans-spinal and peripheral direct current stimulation (tsDCS + pDCS) can modulate muscle tone and potentially improve motor function. Preliminary clinical trial of safety and feasibility (Paget-blanc et al. 2019) suggests that five sessions of transcutaneous spinal direct current stimulation paired with transcutaneous peripheral direct current stimulation (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) temporarily reduce spasticity features such as catch response to slow and fast joint stretch and overall stiffness of the affected extremity with optimal reductions in spasticity occurring 2-3 weeks post stimulation intervention. Unexpectedly, participants also experienced significant improvements in motor function, suggestive that tsDCS+ pDCS may provide a therapeutic window to further augment motor outcomes with robotic wrist training.

The investigators propose a study to evaluate whether two doses of five consecutive days of paired spinal and peripheral noninvasive stimulation combined with six weeks of intensive (three times a week) robotic therapy will significantly alter the clinical and objective measures of spasticity and motor function of the wrist in participants with upper extremity spasticity after stroke.

Study Design


Spasticity as Sequela of Stroke


MyoRegulator™ System


The Feinstein Institutes For Medical Research - Northwell Health
New York
United States




Northwell Health

Results (where available)

View Results


Published on BioPortfolio: 2019-10-09T09:21:42-0400

Clinical Trials [2203 Associated Clinical Trials listed on BioPortfolio]

Spasticity and Treatment Satisfaction Among Stroke Survivors

To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and...

The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct...

Repetitive Transcranial Magnetic Stimulation in Post Stroke Upper Limb Spasticity

The reticulospinal pathway (RSP) is at the center of spasticity mechanism. The RSP indirectly synapses with motor neurons via interneurons in the ventromedial intermediate zone in both hal...

Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity

Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity afte...

Powered Exoskeleton for the Treatment of Elbow Spasticity

This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. ...

PubMed Articles [10100 Associated PubMed Articles listed on BioPortfolio]

Cryotherapy reduces muscle hypertonia, but does not affect lower limb strength or gait kinematics post-stroke: a randomized controlled crossover study.

Based on the premise that spasticity might affect gait post-stroke, cryotherapy is among the techniques used to temporarily reduce spasticity in neurological patients. This effective technique would e...

Influence of positional changes on spasticity of the upper extremity in poststroke hemiplegic patients.

Spasticity commonly occurs in hemiplegic patients with stroke, and clinical experience indicates that upper limb spasticity is more apparent when patients are standing than when they are lying down. F...

Effects of Acupuncture Treatment on Lower Limb Spasticity in Patients Following Hemorrhagic Stroke: A Pilot Study.

Lower limb spasticity is often a significant problem in stoke rehabilitation. The purpose of this study was to investigate the effects of acupuncture treatment on lower limb spasticity in patients fol...

Concurrent Effects of Dry Needling and Electrical Stimulation in the Management of Upper Extremity Hemiparesis.

Stroke is one of leading causes of disability in western countries. A variety of rehabilitation programs for the treatment of patients post stroke have been proposed. We describe the outcomes of a 49-...

The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis.

: To assess the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) to reduce lower limb spasticity in adult stroke survivors.: A systematic review of Medline/Pubmed, CENTRAL, CINAHL, PEDro data...

Medical and Biotech [MESH] Definitions

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

Stroke caused by lacunar infarction or other small vessel diseases of the brain. It features hemiparesis (see PARESIS), hemisensory, or hemisensory motor loss.

A heterogeneous group of nonprogressive motor disorders caused by chronic brain injuries that originate in the prenatal period, perinatal period, or first few years of life. The four major subtypes are spastic, athetoid, ataxic, and mixed cerebral palsy, with spastic forms being the most common. The motor disorder may range from difficulties with fine motor control to severe spasticity (see MUSCLE SPASTICITY) in all limbs. Spastic diplegia (Little disease) is the most common subtype, and is characterized by spasticity that is more prominent in the legs than in the arms. Pathologically, this condition may be associated with LEUKOMALACIA, PERIVENTRICULAR. (From Dev Med Child Neurol 1998 Aug;40(8):520-7)

A vascular anomaly composed of a collection of large, thin walled tortuous VEINS that can occur in any part of the central nervous system but lack intervening nervous tissue. Familial occurrence is common and has been associated with a number of genes mapped to 7q, 7p and 3q. Clinical features include SEIZURES; HEADACHE; STROKE; and progressive neurological deficit.

A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

More From BioPortfolio on "Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke"

Quick Search

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Searches Linking to this Trial