Hemiparesis, Stroke
Conditions
Keywords
neuroplasticity, rehabilitation, transcranial direct current stimulation, motor training
Brief summary
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
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.
Interventions
DEVICEtranscranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
BEHAVIORALintensive upper extremity motor training
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.
Sponsors
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment from baseline | Baseline, Immediately post-intervention, one-month follow-up | This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Research Arm Test from baseline | Baseline, Immediately post-intervention, one-month follow-up | This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function. |
| Change in Stroke Impact Scale from baseline | Baseline, Immediately post-intervention, one-month follow-up | 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. |
| Change in cortical motor map from baseline | Baseline, Immediately post-intervention, one-month follow-up | This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm. |
Countries
United States
Outcome results
None listed