Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

Study Overview
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Brief Summary
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Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

Detailed Description
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This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.

Official Title
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Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Device: transcranial direct current stimulation
* Behavioral: intensive upper extremity motor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 or more months post-stroke Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees Exclusion Criteria: Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment Untreated depression History of multiple strokes Exclusion criteria for TMS evaluations: History of head injury with loss of consciousness History of 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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal tDCS<br>Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. | Device: transcranial direct current stimulation<br>* This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.<br>Behavioral: intensive upper extremity motor training<br>* This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.<br>|
| Experimental: Cathodal tDCS<br>Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. | Device: transcranial direct current stimulation<br>* This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.<br>Behavioral: intensive upper extremity motor training<br>* This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.<br>|
| Experimental: Dual tDCS<br>Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. | Device: transcranial direct current stimulation<br>* This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.<br>Behavioral: intensive upper extremity motor training<br>* This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.<br>|
| Sham Comparator: Sham tDCS<br>Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity. | Device: transcranial direct current stimulation<br>* This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.<br>Behavioral: intensive upper extremity motor training<br>* This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Assessment from baseline | This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function. | Baseline, Immediately post-intervention, one-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Action Research Arm Test from baseline | This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function. | Baseline, Immediately post-intervention, one-month follow-up | 
| Change in Stroke Impact Scale from baseline | This is a self-report measure of 64 items that assess 8 domains, including strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. A score increase indicates an improvement. | Baseline, Immediately post-intervention, one-month follow-up | 
| Change in cortical motor map from baseline | This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm. | Baseline, Immediately post-intervention, one-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroplasticity, rehabilitation, transcranial direct current stimulation, motor training