Stroke
Conditions
Keywords
neuroplasticity, rehabilitation, peripheral nerve stimulation, motor training
Brief summary
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
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.
Interventions
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.
BEHAVIORALIntensive upper extremity motor training
Sponsors
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment | Baseline, Immediately post-intervention | This is a quantitative measure of motor recovery, coordination, and speed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | Baseline, Immediately post-intervention | This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement. |
| Stroke Impact Scale | Baseline, Immediately post-intervention | This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. |
| Cortical motor map volume | Baseline, Immediately post-intervention | This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand. |
Countries
United States
Outcome results
None listed