This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.
Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
Change in Fugl Meyer Assessment
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
Time frame: baseline, post-intervention, 1-month follow-up
Change in Action Arm Research Test (ARAT)
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.
Time frame: baseline, post-intervention, 1-month follow-up
Change in Wolf Motor Function Test (WMFT)
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.
Time frame: baseline, post-intervention, 1-month follow-up
Transcranial Magnetic Stimulation
Time frame: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
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