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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation with motor training | Experimental | 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. |
|
| Sham stimulation with motor training | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S88 Dual Output Stimulator by Grass Technologies | Device | Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, post-intervention, 1-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, post-intervention, 1-month follow-up |
| Change in Wolf Motor Function Test (WMFT) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27188405 | Derived | Carrico C, Chelette KC 2nd, Westgate PM, Powell E, Nichols L, Fleischer A, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training in Chronic, Severe Motor Deficit After Stroke: A Randomized Trial. Stroke. 2016 Jul;47(7):1879-84. doi: 10.1161/STROKEAHA.116.012671. Epub 2016 May 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | baseline, post-intervention, 1-month follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lumy Sawaki | University of Kentucky | lsawa2@uky.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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. |
| baseline, post-intervention, 1-month follow-up |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | baseline, post-intervention, 1-month follow-up |
|
|
|
| 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. | Posted | Mean | Standard Error | log(seconds) | baseline, post-intervention, 1-month follow-up |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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 | 0 | 18 | 0 | 18 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |