An interventional study of S88 Dual Output Stimulator by Grass Technologies in Stroke and Cerebrovascular Accident, sponsored by Lumy Sawaki. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Lumy Sawaki · Not applicable, Interventional, and Treatment
This research project addresses a scientifically important question that cannot be answered by other means. The use of peripheral nerve stimulation has the potential to enhance recovery in subacute stroke patients with poor functional recovery. The primary objective of this proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor training has the ability to further improve hand motor function when compared to intensive training alone or nerve stimulation alone. The results from this study have the potential to develop new strategies in neurorehabilitation.
Stroke is the leading cause of long-term disability in the United States. Approximately 70-88% of persons with ischemic stroke have some degree of motor impairment. A major goal of research in stroke rehabilitation is to harness the ability of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. 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 (PNS) can be successfully combined to physical training, especially in poorly recovered subacute stroke patients. The proposed study will evaluate the effectiveness of sustained PNS coupled with motor training, to improve hand motor function in subacute stroke patients with severe motor deficit. Our preliminary data in chronic stroke patients with severe motor deficit demonstrate that motor function can be substantially enhanced when PNS is paired with motor training. In addition, a separate study in patients with mild motor deficit receiving motor training alone suggests that the optimal therapeutic time window to deliver motor training is within the first year after stroke. The improvement of behavioral motor function was associated with corticomotor reorganization. Therefore, this study proposes to evaluate the effectiveness of sustained PNS paired with motor training, to promote functional motor recovery in subacute stroke patients with severe motor deficit. The central hypothesis is that subacute stroke patients with severe motor deficit receiving PNS and intensive task-oriented therapy will have improved motor function compared to patients receiving sham-PNS and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation. The investigators plan to accept or reject the central hypothesis by accomplishing two Specific Aims: 1) test the effect of PNS preceding task-oriented therapy on hand motor function, and 2) test the effect of PNS preceding task-oriented therapy on motor map measured by transcranial magnetic stimulation. The long-range goals are: a) to maximize the restoration of hand motor function after stroke, b) to determine the impact of this intervention in activities of daily living, and c) collect solid data to prepare for a future multicenter randomized clinical trial.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 73 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
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.
Device: S88 Dual Output Stimulator by Grass Technologies
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.
Device: S88 Dual Output Stimulator by Grass Technologies
Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
Change in Fugl Meyer Assessment
The upper extremity FMA is a quantitative measure of motor recovery, sensation, coordination, and speed.
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Action Arm Research Test (ARAT)
The ARAT was developed specifically to measure UE changes and consists of 4 specific tests to measure grasp, grip, pinch, and gross movement.
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Wolf Motor Function Test (WMFT)
The WMFT is a time- and function-based evaluation encompassing a battery of 17 tasks
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Stroke Impact Scale (SIS)
The SIS is a self-report measure that includes 64 items assessing 8 domains including strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation.
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Lumy Sawaki