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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants are being asked to participate in a research study conducted by Shih-Chiao Tseng, PT, Ph.D. at Texas Woman's University. This research study is to determine whether low-intensive brain stimulation can enhance learning of a leg movement task. The investigators also want to know if brain stimulation can improve the nerve function and walking performance. Our goal is to understand any relationship between brain stimulation and overall movement control improvement. Participants have been invited to join this research if they have had a stroke before or they are healthy adults aged 21 years or older. Research evidence shows stroke can induce permanent brain damage and therefore may cause a person to have trouble learning a new task. This in turn may significantly impact the recovery of motor function in stroke survivors. In addition, the investigators also want to know how a healthy person learns this new leg task and see if her/his learning pattern differs from a stroke survivor. This study comprises two phases: Phase I study investigates short-term effects of brain stimulation on leg skill learning and only requires two visits to TWU. The total time commitment for Phase I study will be about 6.5 hours, 3.5 hours on the first visit and three hours on the second visit; Phase II study is an expanded version of Phase I study to investigate long-term effects of brain stimulation on leg skill learning and requires to complete 12 visits of exercise training paired with brain stimulation over a four-week period and additional one visit for follow-up test. The total time commitment for Phase II study will be about 20 hours, a total of 18 hours for 12 exercise training sessions and two hours for a follow-up test. The investigators hypothesize that people with chronic stroke will show a slower rate of acquiring this leg skill as compared to healthy adults. The investigators also hypothesize that co-applying brain stimulation with 12 sessions of exercise training will enhance skill learning of this leg task for people with chronic stroke and this 12-session exercise program may exert beneficial influences on the nerve function and leg muscle activation, and consequentially improve motor control for walking.

Research Team

Shih-Chiao Tseng, PT, PhD

Principal Investigator

Texas Woman's University School of Physical Therapy

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+