Back to resultsHand Rehabilitation Study for Stroke Patients (DOSES)
Primary Purpose
Upper Extremity Paresis, Disability Physical, Chronic Stroke
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Somatosensory Electrical Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Upper Extremity Paresis
Eligibility 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.
Sites / Locations
- University of California, San Francisco
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Modified Ashworth Scale
standard instrument
Change in Arm Research Action Test
standard instrument
Full Information
NCT ID
NCT03148106
First Posted
March 8, 2017
Last Updated
August 1, 2022
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03148106
Brief Title
Hand Rehabilitation Study for Stroke Patients
Acronym
DOSES
Official Title
Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Paresis, Disability Physical, Chronic Stroke, Motor Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Somatosensory Electrical Stimulation
Other Intervention Name(s)
transcutaneous electrical nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Finger Fractionation
Description
Ability to fractionate movement can be assessed by asking the patient to move one segment in isolation and keep other, adjacent segments still.
Time Frame
Baseline and immediately post-stimulation
Secondary Outcome Measure Information:
Title
Change in Modified Ashworth Scale
Description
standard instrument
Time Frame
Baseline and immediately post-stimulation
Title
Change in Arm Research Action Test
Description
standard instrument
Time Frame
Baseline and immediately post-stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karunesh Ganguly, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hand Rehabilitation Study for Stroke Patients
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