Repetitive Nerve Stimulation to Improve Recovery After Stroke

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT03956407
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-12-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Jebsen-Taylor Test	Immediately after one session of intervention	Test of upper limb dexterity

Secondary Outcome Measures

Name	Time	Method
Change in lateral pinch strength	Immediately after one session of intervention	Pinch strength measured with dynamometer
Change in gamma-aminobutyric acid levels in primary motor cortex	Immediately after one session of intervention	Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
Change in brain perfusion	Immediately after one session of intervention	Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
Change in grasp strength	Immediately after one session of intervention	Grasp strength measured with dynamometer

Trial Locations

Locations (1)

Hospital São Rafael; 🇧🇷 Salvador, BA, Brazil