Brain Stimulation for Stroke Recovery

(Gait Trial)

Overseen By Shih-Chiao Tseng, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Woman's University

Disqualifiers: Pregnancy, Metal implants, Seizures, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether gentle brain stimulation, specifically transcranial direct current stimulation (tDCS), can improve walking and movement control in stroke survivors. Researchers aim to determine if this technique can facilitate learning new leg movements and enhance nerve and muscle function. The study compares stroke survivors with healthy individuals to understand differences in learning new tasks. Those who had a stroke more than six months ago, experience movement issues in one leg, and can walk independently might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance rehabilitation methods for stroke survivors.

Do I need to stop my current medications for the trial?

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 brain stimulation technique is safe for stroke recovery?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. Only about 11.62% of studies report any side effects, with the most common being mild itching and burning sensations on the scalp, which are usually temporary and not serious.

Studies have also confirmed that tDCS is safe at doses of 2 mA or 4 mA, even when combined with other treatments for stroke patients. These studies found no serious harm. While some research focuses on early stroke recovery, the safety data is reassuring for long-term use.

Overall, tDCS has a good safety record, making it a promising option for aiding stroke recovery and improving movement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for stroke recovery because it offers a novel approach to enhance brain function. Unlike standard treatments that focus on physical therapy and medication, tDCS uses a non-invasive electrical stimulation technique to directly target and stimulate the brain's motor cortex. This method may improve stepping reaction times and leg muscle activation, potentially leading to faster and more effective rehabilitation for stroke survivors. By comparing stroke patients' improvements to those of healthy adults, researchers aim to better understand the potential of tDCS to bring about significant functional recovery.

What evidence suggests that this brain stimulation technique is effective for stroke recovery?

This trial will explore the effects of transcranial direct current stimulation (tDCS) on stroke recovery. Studies have shown that tDCS might improve movement skills in stroke patients. Research suggests that tDCS can be safe and may aid recovery by enhancing nerve function and control over movements. However, results vary, with some studies showing more positive outcomes than others. Some evidence indicates that tDCS can assist in learning new movements, which could benefit stroke recovery. Overall, while tDCS shows promise, more research is needed to consistently confirm its effectiveness. ^{2 3 6 7 8}

Who Is on the Research Team?

Shih-Chiao Tseng, PT, PhD

Principal Investigator

Texas Woman's University School of Physical Therapy

Are You a Good Fit for This Trial?

This trial is for adults aged 21+ who have had a stroke or are healthy with no neurological issues. Stroke survivors must be able to stand and walk independently, have certain levels of vision and cognitive function, and their stroke should be at least 6 months old affecting the corticospinal tract but not other brain areas.

Inclusion Criteria

I have had a stroke but can move my hips and knees without help.

You need to score 24 or higher on a test that checks your memory and thinking skills.

I can stand on my own for more than 30 seconds.

Exclusion Criteria

I have a condition that limits my ability to exercise.

I struggle to understand or follow simple instructions.

Presence of any metal implants, cardiac pacemakers, or history of seizures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase I Study

Short-term effects of brain stimulation on leg skill learning with two visits

1-2 weeks

2 visits (in-person)

Phase II Study

Long-term effects of brain stimulation with 12 exercise training sessions over four weeks

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in learning capacity and motor function after training

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial direct current stimulation (tDCS)

Trial Overview The study tests if low-intensity brain stimulation (tDCS) can help improve leg movement learning and walking in people who've had a stroke compared to healthy individuals. It includes short-term effects with two visits, and long-term effects requiring twelve exercise sessions plus follow-up.

How Is the Trial Designed?

Group I: Effects of brain stimulation on functional improvements Experimental Treatment 1 Intervention

To determine the effect of brain stimulation (tDCS) on functional improvements in stroke survivors. Specifically, the investigators will compare stepping reaction time, cortical neuronal activity, peripheral nerve activity, and walking function in the stroke survivors before and after tDCS, and also compared these findings with results from healthy adults. The investigators will answer the question: "Do stroke survivors shorten stepping reaction time and improve leg muscle activation and gait performance after tDCS, and these improvements are at a similar rate as compared to data collected from healthy young and older adults?"

Group II: Brain stimulation-induced improvements in leg skill learning Experimental Treatment 1 Intervention

To examine the degree of stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group. Up to date, most studies have investigated the effects of brain stimulation on hand skill improvements in healthy young adults; little is known about stimulation-induced improvement in the "leg" skill improvement in stroke survivors as well as in older healthy adults. The investigators will answer the question: "Do stroke survivors improve leg skill learning at a comparable rate as healthy young and older adults after brain stimulation "transcranial direct current stimulation" (tDCS)?"

Group III: Effects of brain stimulation combined with stepping training Placebo Group 1 Intervention

After enrolling to the study, participants with chronic stroke will be randomly assigned to one of two groups: anodal tDCS or sham tDCS groups. All subjects will then undergo a total of twelve training sessions over four weeks in which subjects will learn a novel visuomotor stepping task immediately after visuomotor learning training while 20-minute tDCS (anodal or sham stimulation) is delivered over the leg area of primary motor cortex.The investigators will measure changes in brain neuronal activity, peripheral nerve activity, and walking performance before and after a 12-session training program, and will follow up one week later.

Transcranial direct current stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial direct current stimulation for:

• Stroke rehabilitation
• Depression
• Chronic pain

Approved in European Union as Transcranial direct current stimulation for:

• Stroke rehabilitation
• Major depressive disorder
• Chronic pain

Approved in Canada as Transcranial direct current stimulation for:

• Stroke rehabilitation
• Depression
• Chronic pain

Who Is Running the Clinical Trial?

Texas Woman's University

Lead Sponsor

Trials

90

Recruited

5,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7153501/

Transcranial Direct Current Stimulation for Post-Stroke ... However, data on tDCS efficacy in stroke motor recovery have been mixed and inconsistent, leaving several issues to be resolved before tDCS is ready for ...

2. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(25)00044-4/abstract

Safety and efficacy of transcranial direct current stimulation ... tDCS at doses of 2 mA or 4 mA, in addition to mCIMT, did not lead to further reduction in motor impairment in patients 1–6 months after stroke, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3600193/

Transcranial Direct Current Stimulation in Stroke Rehabilitation Transcranial direct current stimulation (tDCS) is a promising technique to treat a wide range of neurological conditions including stroke.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442225000444

Safety and efficacy of transcranial direct current stimulation ... tDCS at doses of 2 mA or 4 mA, in addition to mCIMT, did not lead to further reduction in motor impairment in patients 1–6 months after stroke, but it was safe, ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000204444

Efficacy of Transcranial Direct Current Stimulation on ... This study actively aims to thoroughly evaluate the effectiveness of tDCS in alleviating post-stroke fatigue and strives to make significant contributions to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ... Only 11.62% of published papers reported the occurrence of tDCS adverse effects in stroke patients. The most common was itching (70%), followed by burning ...

7. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.113.001687

Safety and Efficacy of Transcranial Direct Current ... Our data indicate that transcranial direct current stimulation exerts a measurable neuroprotective effect in the acute phase of stroke. However, ...

8. nature.com nature.com/articles/s41598-024-51839-5

Safety of ipsilesional anodal transcranial direct current ... In this present study, we aimed to evaluate structural and behavioral safety of anodal tDCS applied in the acute phase of stroke.