Repetitive Nerve Stimulation to Improve Recovery After Stroke (RESTORES)
February 26, 2025 updated by: Hospital Israelita Albert Einstein
Comparison Between Mechanisms Underlying Effects of Repetitive Peripheral Nerve Stimulation on Upper Limb Motor Performance in the Subacute and Chronic Phases After Stroke
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BA
-
Salvador, BA, Brazil, 41253-190
- Hospital Sao Rafael
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Other: Subthreshold, subacute stroke
Other: Subthreshold RPSS + Motor Training.
Subthreshold RPSS will be administered for 2 hours.
After RPSS, the patient will receive motor training
|
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.
|
|
Experimental: 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.
|
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.
|
|
Other: Subthreshold, chronic stroke
Other: Subthreshold RPSS + Motor Training.
RPSS will be administered for 2 hours.
After RPSS, the patient will receive motor training
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Jebsen-Taylor Test
Time Frame: Immediately after one session of intervention
|
Test of upper limb dexterity
|
Immediately after one session of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lateral pinch strength
Time Frame: Immediately after one session of intervention
|
Pinch strength measured with dynamometer
|
Immediately after one session of intervention
|
|
Change in gamma-aminobutyric acid levels in primary motor cortex
Time Frame: Immediately after one session of intervention
|
Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
|
Immediately after one session of intervention
|
|
Change in brain perfusion
Time Frame: Immediately after one session of intervention
|
Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
|
Immediately after one session of intervention
|
|
Change in grasp strength
Time Frame: Immediately after one session of intervention
|
Grasp strength measured with dynamometer
|
Immediately after one session of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
November 30, 2022
Study Registration Dates
First Submitted
May 16, 2019
First Submitted That Met QC Criteria
May 17, 2019
First Posted (Actual)
May 20, 2019
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3019629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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