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Hand Rehabilitation Study for Stroke Patients (DOSES)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Active, not recruiting

Conditions

Upper Extremity Paresis
Motor Disorders
Chronic Stroke
Disability Physical

Treatments

Device: Somatosensory Electrical Stimulation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03148106
13-12346
R01MH111871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Somatosensory Electrical Stimulation
Experimental group
Treatment:
Device: Somatosensory Electrical Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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