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Peripheral Nerve Stimulation and Motor Training in Stroke

NCT02658578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-07-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

PNS

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.

Sponsors & Collaborators

  • Fundação Faculdade de Medicina

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • The Cleveland Clinic

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Adriana Conforto, MD PhD · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/ Fundação Faculdade de Medicina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-03-31
Completion
2021-03-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02658578 on ClinicalTrials.gov