Hand Rehabilitation for Stroke

(DOSES Trial)

Overseen By Adelyn Tu-Chan, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnant, Severe cardiovascular, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-stimulation

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

How does the treatment of electrical nerve stimulation for hand rehabilitation after a stroke differ from other treatments?

This treatment is unique because it uses electrical nerve stimulation to specifically target the hand, aiming to improve motor control and reduce muscle stiffness, which is different from other therapies that may not focus on the hand or use electrical stimulation. ^{1 2 3}

Who Is on the Research Team?

Karunesh Ganguly, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who have hand movement issues due to a stroke that happened over 6 months ago. It's not suitable for pregnant individuals, those with severe muscle stiffness or limited finger motion, serious health conditions like heart disease, communication problems from the stroke, pacemakers, active cancer, major hand deformities not caused by stroke, recent substance abuse or untreated depression.

Inclusion Criteria

You still have trouble moving your hand because of a stroke that happened more than 6 months ago.

Exclusion Criteria

Pregnant

You have severe muscle stiffness with a score higher than 3 on the MAS scale.

You can't move your fingers at least 10 degrees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous electrical nerve stimulation (TENS) for short-term improvement of hand dysfunction

Immediate post-stimulation

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Nerve Stimulation
• Hand Rehabilitation Study

Trial Overview The study tests electrical nerve stimulation using a TENS unit to improve short-term hand function in stroke survivors. The aim is to determine the best settings for this treatment and understand its effectiveness as part of developing long-term rehabilitation programs.

How Is the Trial Designed?

Group I: Somatosensory Electrical Stimulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. Sweden pubmed.ncbi.nlm.nih.gov

Mesh-glove. 2. Modulation of residual upper limb motor control after stroke with whole-hand electric stimulation. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Artificial grasping system for the paralyzed hand. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Influence of surface peripheral electrical stimulation on nerve regeneration after digital nerve neurorrhaphy: study protocol for a randomized clinical trial. [2022]