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Brain Stimulation

Brain Stimulation for Stroke Recovery (Gait Trial)

N/A

Recruiting

Led By Shih-Chiao Tseng, PT, PhD

Research Sponsored by Texas Woman's University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to maintain standing position without any assistance for more than 30 sec.

Individuals with chronic stroke have no passive range of motion limitation in bilateral hips and knees. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or ess.

Must not have

Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training

Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measure changes in the step length symmetry before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation.

Summary

This trial is testing whether low-intensity brain stimulation can help people with or without a stroke learn a new leg movement task, and if it can help improve nerve function and walking performance. The trial will involve two phases, with Phase I requiring two visits and Phase II requiring 12 visits over four weeks.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the electrode site on the head, itching or tingling during stimulation, headache, fatigue, nausea or dizziness. These are usually mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I had a stroke but can move my hips and knees freely, with only slight ankle movement limits.

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My vision reaches 20/20 with glasses or contacts.

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

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I can walk on my own for 10 meters, with or without help like a cane.

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I do not have any ongoing neurological or musculoskeletal issues.

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I had a stroke affecting one side of my brain over 6 months ago.

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I can walk on my own for 10 meters, with or without help like a cane.

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I am a healthy adult with no ongoing brain or muscle/bone problems.

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I have weakness on one side of my body due to a past stroke.

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I have lasting weakness on one side of my body affecting my leg due to a past stroke.

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I had a stroke over 6 months ago affecting my brain's movement pathway.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that limits my ability to exercise.

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I struggle to understand or follow simple instructions.

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I have balance issues or unstable chest pain.

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My brain scans show damage or tumors in specific areas or multiple locations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measure changes in the nerve function before training, up to 24 hours after the completion of a 12-session training program), and one week after the completion of a 12-session training program.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measure changes in the nerve function before training, up to 24 hours after the completion of a 12-session training program), and one week after the completion of a 12-session training program.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measure changes in the nerve function before training, up to 24 hours after the completion of a 12-session training program), and one week after the completion of a 12-session training program. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in nerve function (Phase I)

Changes in nerve function (Phase II)

Changes in stepping reaction time (Phase I)

+3 more

Secondary study objectives

Fugl-Meyer Lower Extremity Function Assessment (Phase I)

Lower Extremity

Mini-mental State Examination (Phase I)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Effects of brain stimulation on functional improvementsExperimental Treatment1 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 learningExperimental Treatment1 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 trainingPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation (tDCS)

2016

Completed Phase 3

~890

0 / 17Eligibility criteria met