Hand Rehabilitation Study for Stroke Patients

NCT ID: NCT03148106

Last Updated: 2025-05-25

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2028-12-01

Brief Summary

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The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.

Detailed Description

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Conditions

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Upper Extremity Paresis Disability Physical Chronic Stroke Motor Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somatosensory Electrical Stimulation

Group Type EXPERIMENTAL

Somatosensory Electrical Stimulation

Intervention Type DEVICE

The investigators will put adhesive electrodes on the affected arm and connect it to a device that will deliver a gentle electrical stimulation to the hand and arm. The stimulation will last for different amounts of time, depending on the stimulation condition. This can be 30 minutes twice a day (1 hour apart), 1 hour continuously, 2 hours continuously, or 3 hours continuously. The stimulation conditions will also vary in stimulation strength. It is normal that some people may feel a tingling sensation, while others may feel nothing.

Interventions

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Somatosensory Electrical Stimulation

The investigators will put adhesive electrodes on the affected arm and connect it to a device that will deliver a gentle electrical stimulation to the hand and arm. The stimulation will last for different amounts of time, depending on the stimulation condition. This can be 30 minutes twice a day (1 hour apart), 1 hour continuously, 2 hours continuously, or 3 hours continuously. The stimulation conditions will also vary in stimulation strength. It is normal that some people may feel a tingling sensation, while others may feel nothing.

Intervention Type DEVICE

Other Intervention Names

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transcutaneous electrical nerve stimulation

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years, has residual hand motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to enrollment.

Exclusion Criteria

* Pregnant; uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease; active cancer; significant hand joint deformity or other diagnosis with major effect on hand function besides stroke; severe alcohol or drug abuse within the past year; untreated or inadequately treated major depression; spasticity score \>3 on the MAS; lack of finger range of motion of at least 10 degrees; severe aphasia or other communicative, behavioral or cognitive impairment that significantly interferes with the participant's ability to comply with the protocol or provide informed consent. In addition, patients will be excluded if they have a pacemaker.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karunesh Ganguly, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH111871

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-12346

Identifier Type: -

Identifier Source: org_study_id

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