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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to use electrical nerve stimulation to improve hand function in people who have had a stroke. The goal is to determine how to apply this therapy in the short term, potentially leading to a long-term rehabilitation program that enhances hand use in daily life. Participants will use a device that sends gentle electrical signals to the skin of the affected arm. This trial suits those who had a stroke over six months ago and still experience hand movement issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance rehabilitation options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this electrical nerve stimulation is safe for hand rehabilitation after a stroke?

Studies have shown that electrical nerve stimulation is generally safe and well-tolerated for stroke recovery. Research indicates that this treatment can improve movement in stroke patients. Although the exact mechanism remains unclear, it typically does not cause serious side effects. Some individuals might experience mild tingling or discomfort during the treatment, but these sensations are usually minor and resolve quickly. Overall, electrical nerve stimulation has been used safely in many rehabilitation settings, making it a reliable option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stroke-related hand rehabilitation focus on physical therapy exercises and traditional occupational therapy methods. Unlike these standard options, Somatosensory Electrical Stimulation (SES) is unique because it uses gentle electrical currents to stimulate nerves in the hand. This approach aims to enhance nerve communication and potentially accelerate recovery of hand function after a stroke. Researchers are excited about SES because it offers a new way to activate the brain's natural plasticity, which could lead to more effective rehabilitation outcomes compared to conventional methods.

What evidence suggests that electrical nerve stimulation is effective for hand dysfunction after a stroke?

Research has shown that electrical nerve stimulation, which participants in this trial may receive, can improve hand function after a stroke. Studies have found that combining this stimulation with regular rehabilitation boosts motor skills. For instance, one study found that patients experienced better hand function after sessions of nerve stimulation. Another study observed improvements in motor skills when electrical stimulation was added to standard therapy. These findings suggest that applying electrical stimulation to the skin can effectively help regain hand movement and strength after a stroke. ^{2 3 5 6 7}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2824782/

Effects of Somatosensory Stimulation on Motor Function After ... These results indicate that multiple sessions of RPSS could facilitate training effects on motor function after subacute stroke depending on the intensity of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03148106

Hand Rehabilitation Study for Stroke Patients 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877065718314088

Adding electrical stimulation during standard rehabilitation ... Electrical sensory input can contribute to routine rehabilitation to improve early post-stroke lower-extremity impairment and late motor function.

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/1545968318799496

Electrical Somatosensory Stimulation in Early ... Background. Arm paresis is present in 48% to 77% of acute stroke patients. Complete functional recovery is reported in only 12% to 34%.

5. nature.com nature.com/articles/s41598-018-27553-4

Effects of 8-week sensory electrical stimulation combined ... Celnik and colleagues27 found that the hand function of chronic stroke subjects improved immediately after two-hour peripheral nerve ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7005350/

Rewiring the Lesioned Brain: Electrical Stimulation for Post ... Electrical stimulation has been extensively applied in post-stroke motor restoration, but its treatment mechanisms are not fully understood.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5683582/

Effects of somatosensory electrical stimulation on motor ... Results of kinematic and clinical outcome measurements are presented in Table 2. Mean scores were significantly improved after peripheral nerve ...