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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS076348 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fundação Faculdade de Medicina | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| The Cleveland Clinic | OTHER |
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Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. The investigators will non-invasively stimulate peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of motor training in patients in the chronic stage after stroke.
The objective of this protocol is to determine whether a neuromodulation intervention associated with functional electrical stimulation, when combined with task-specific training over several sessions, decreases upper limb motor disability, motor impairment, overall disability and improves quality of life compared to the sham intervention and functional electrical stimulation.
The interventions will consist of three sessions per week, over six weeks, of outpatient functional electrical stimulation of the paretic wrist and task-specific training. In each session, either active peripheral nerve stimulation (PNS) or sham PNS will be applied. Before the first session, patients will be familiarized with the procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PNS | Active Comparator | Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. |
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| Sham PNS | Placebo Comparator | In sham PNS, the median, ulnar and radial nerves will not be actively stimulated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNS | Procedure | Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. In sham PNS, the median, ulnar and radial nerves will not be actively stimulated. |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity Log | This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Active range of motion of wrist extension in the paretic side |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana Conforto, MD PhD | Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34587830 | Derived | Conforto AB, Machado AG, Ribeiro NHV, Plow EB, Liew SL, da Costa Leite C, Zavaliangos-Petropulu A, Menezes I, Dos Anjos SM, Luccas R, Peckham PH, Cohen LG. Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1059-1064. doi: 10.1177/15459683211046259. Epub 2021 Sep 29. | |
| 32269549 | Derived | Conforto AB, Machado AG, Menezes I, Ribeiro NHV, Luccas R, Pires DS, Leite CDC, Plow EB, Cohen LG. Treatment of Upper Limb Paresis With Repetitive Peripheral Nerve Sensory Stimulation and Motor Training: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2020 Mar 25;11:196. doi: 10.3389/fneur.2020.00196. eCollection 2020. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention.
| 18 weeks |
| Active range of motion of wrist flexion in the paretic side | This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Grasp force in the paretic side | This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Grip force in the paretic side | This physiological parameter will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Fugl-Meyer Assessment of Sensorimotor Recovery | This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Barthel Index | This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Stroke Impact Scale | This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Beck Depression Inventory-short Form | This questionnaire will be evaluated before the intervention and 3, 6, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Wolf Motor Function Test | This scale as a secondary outcome will be evaluated before the intervention and 3, 10 and 18 weeks after the beginning of the intervention. | 18 weeks |
| Modified Ashworth Scale | This scale will be evaluated before the intervention and 3, 6, 10 and 18 weeks | 18 weeks |
| Minimal Clinically Important Difference - Wolf Motor Function Test - time | This outcome will be evaluated at 6, 10 and 18 weeks | 18 weeks |
| Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale | This outcome will be evaluated at 6, 10 and 18 weeks | 18 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |