Hand Rehabilitation Study for Stroke Patients (DOSES)

Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Motor Disorders; Upper Extremity Paresis; Disability Physical; Chronic Stroke
• Intervention / Treatment: Device: Somatosensory Electrical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Somatosensory Electrical Stimulation

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 Names: transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Ashworth Scale	standard instrument	Baseline and immediately post-stimulation
Change in Arm Research Action Test	standard instrument	Baseline and immediately post-stimulation

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Karunesh Ganguly, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis; Motor Disorders
• Other Study ID Numbers: 13-12346; R01MH111871 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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