Repetitive Nerve Stimulation to Improve Recovery After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-11-30

Brief Summary

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Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

An amendment for performance of a minimization procedure in order to enhance the probability of comparable characteristics between the groups was approved. The researcher responsible for minimization is not involved in data collection or analysis.

Study Groups

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Suprathreshold, subacute stroke

Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPES, the patient will receive motor training.

Group Type EXPERIMENTAL

Suprathreshold repetitive peripheral sensory stimulation

Intervention Type DEVICE

Suprathreshold repetitive peripheral sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.

Subthreshold, subacute stroke

Other: Subthreshold RPSS + Motor Training. Subthreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training

Group Type OTHER

Subthreshold repetitive sensory stimulation

Intervention Type DEVICE

Subthreshold repetitive sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.

Suprathreshold, chronic stroke

Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training.

Group Type EXPERIMENTAL

Suprathreshold repetitive peripheral sensory stimulation

Intervention Type DEVICE

Suprathreshold repetitive peripheral sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.

Subthreshold, chronic stroke

Other: Subthreshold RPSS + Motor Training. RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training

Group Type OTHER

Subthreshold repetitive sensory stimulation

Intervention Type DEVICE

Subthreshold repetitive sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.

Interventions

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Suprathreshold repetitive peripheral sensory stimulation

Suprathreshold repetitive peripheral sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.

Intervention Type DEVICE

Subthreshold repetitive sensory stimulation

Subthreshold repetitive sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase).
* Ability to perform at least 4 of 7 tasks performed in daily life that is part of the Jebsen-Taylor Test

Exclusion Criteria

* Anesthesia of the paretic hand.
* Lesions affecting the motor cortex (hand area).
* Lesions affecting cerebellum, or cerebellar pathways in the brainstem.
* Severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the Modified Ashworth Scale.
* Neurological diseases such as Parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency.
* Elbow pain or join deformity in the paretic limb.
* Pregnancy.
* Uncontrolled psychiatric disease.
* Aphasia or severe cognitive deficit.
* Inability to provide consent.
* Inability to attend the experimental sessions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No