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Hand Rehabilitation Study for Stroke Patients (DOSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148106
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : March 19, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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, we 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.We 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.

Condition or disease Intervention/treatment Phase
Upper Extremity Paresis Disability Physical Chronic Stroke Motor Disorders Device: Somatosensory Electrical Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Intervention Details:
  • Device: Somatosensory Electrical Stimulation
    We 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.
    Other Name: transcutaneous electrical nerve stimulation


Primary Outcome Measures :
  1. Change in Finger Fractionation [ Time Frame: Baseline and immediately post-stimulation ]
    Ability to fractionate movement can be assessed by asking the patient to move one segment in isolation and keep other, adjacent segments still.


Secondary Outcome Measures :
  1. Change in Modified Ashworth Scale [ Time Frame: Baseline and immediately post-stimulation ]
    standard instrument

  2. Change in Arm Research Action Test [ Time Frame: Baseline and immediately post-stimulation ]
    standard instrument



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148106


Contacts
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Contact: Adelyn Tu-Chan, DO 415-575-0401 adelyn.tu@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Adelyn Tu-Chan, DO    415-575-0401      
Principal Investigator: Karunesh Ganguly, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Mental Health (NIMH)
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03148106    
Other Study ID Numbers: 13-12346
R01MH111871 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Paresis
Motor Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders