Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

Study Overview
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Brief Summary
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Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Detailed Description
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This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.

Official Title
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Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Peripheral nerve stimulation (PNS)
* Behavioral: Intensive upper extremity motor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have severe upper extremity motor deficit after a single stroke Stroke onset at least 12 months ago Exclusion Criteria: Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment Untreated depression History of multiple strokes History of seizure History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness Positive pregnancy test or being of childbearing age and not using appropriate contraception Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain Cardiac or neural pacemakers or implanted medication pumps Receptive aphasia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active PNS during training<br>Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm. | Device: Peripheral nerve stimulation (PNS)<br>* Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.<br>Behavioral: Intensive upper extremity motor training<br> <br> |
| Active Comparator: Active PNS before training<br>Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm. | Device: Peripheral nerve stimulation (PNS)<br>* Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.<br>Behavioral: Intensive upper extremity motor training<br> <br> |
| Sham Comparator: Sham PNS during training<br>Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm. | Device: Peripheral nerve stimulation (PNS)<br>* Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.<br>Behavioral: Intensive upper extremity motor training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | This is a quantitative measure of motor recovery, coordination, and speed. | Baseline, Immediately post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement. | Baseline, Immediately post-intervention | 
| Stroke Impact Scale | This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. | Baseline, Immediately post-intervention | 
| Cortical motor map volume | This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand. | Baseline, Immediately post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroplasticity, rehabilitation, peripheral nerve stimulation, motor training