Cerebrovascular Accident, Stroke
Conditions
Keywords
motor recovery, neuroplasticity, chronic, human, sensory
Brief summary
This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in poorly recovered stroke patients. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy.
Detailed description
Stroke is one of the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training especially in poorly recovered stroke patients. This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in stroke patients with severe motor deficit. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation.
Interventions
Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
Sponsors
Lumy Sawaki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic stroke patients * Single stroke * Chronic (more than 12 months after from stroke) * At least 21 years old, but there is no upper age range for this project. * Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Exclusion criteria
* History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies * History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness * Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery * Cognitive deficit severe enough to preclude informed consent * Positive pregnancy test or being of childbearing age and not using appropriate contraception * Participants with history of untreated depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl Meyer Assessment Motor Score | baseline, post-intervention, 1-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Arm Research Test (ARAT) | baseline, post-intervention, 1-month follow-up | Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance. |
| Change in Wolf Motor Function Test (WMFT) | baseline, post-intervention, 1-month follow-up | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Stimulation With Motor Training 2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy | 18 |
| Sham Stimulation With Motor Training 2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Active Stimulation With Motor Training | Sham Stimulation With Motor Training | Total |
|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 12.1 | 65.4 years STANDARD_DEVIATION 10.8 | 62.1 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change in Fugl Meyer Assessment Motor Score
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Stimulation With Motor Training | Change in Fugl Meyer Assessment Motor Score | Post-intervention minus baseline | 7.4 units on a scale | Standard Error 1 |
| Active Stimulation With Motor Training | Change in Fugl Meyer Assessment Motor Score | 1-month follow-up minus baseline | 7.2 units on a scale | Standard Error 1.3 |
| Sham Stimulation With Motor Training | Change in Fugl Meyer Assessment Motor Score | Post-intervention minus baseline | 3.4 units on a scale | Standard Error 1 |
| Sham Stimulation With Motor Training | Change in Fugl Meyer Assessment Motor Score | 1-month follow-up minus baseline | 2.8 units on a scale | Standard Error 1.4 |
Secondary
Change in Action Arm Research Test (ARAT)
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.
Time frame: baseline, post-intervention, 1-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Stimulation With Motor Training | Change in Action Arm Research Test (ARAT) | Post-intervention minus baseline | 6.4 units on a scale | Standard Error 1.1 |
| Active Stimulation With Motor Training | Change in Action Arm Research Test (ARAT) | 1-month follow-up minus baseline | 6.9 units on a scale | Standard Error 1.3 |
| Sham Stimulation With Motor Training | Change in Action Arm Research Test (ARAT) | Post-intervention minus baseline | 2.3 units on a scale | Standard Error 1.1 |
| Sham Stimulation With Motor Training | Change in Action Arm Research Test (ARAT) | 1-month follow-up minus baseline | 2.4 units on a scale | Standard Error 1.4 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Stimulation With Motor Training | Change in Wolf Motor Function Test (WMFT) | Post-intervention minus baseline | -0.18 log(seconds) | Standard Error 0.03 |
| Active Stimulation With Motor Training | Change in Wolf Motor Function Test (WMFT) | 1-month follow-up minus baseline | -0.14 log(seconds) | Standard Error 0.03 |
| Sham Stimulation With Motor Training | Change in Wolf Motor Function Test (WMFT) | Post-intervention minus baseline | -0.06 log(seconds) | Standard Error 0.03 |
| Sham Stimulation With Motor Training | Change in Wolf Motor Function Test (WMFT) | 1-month follow-up minus baseline | -0.07 log(seconds) | Standard Error 0.04 |