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Relocation of PI
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Experimental | 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. |
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| Cathodal tDCS | Experimental | 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. |
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| Dual tDCS | Experimental | 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. |
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| Sham tDCS | Sham Comparator | Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for TMS evaluations:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky at Cardinal Hill Rehabilitation Hospital | Lexington | Kentucky | 40504 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| intensive upper extremity motor training | Behavioral | 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. |
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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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |