← Back to Search

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.

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.

Awards & highlights

Gait Trial 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.Check my eligibility

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.See study design

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.

Gait Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

Select...

My vision reaches 20/20 with glasses or contacts.

Select...

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

Select...

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

Select...

I do not have any ongoing neurological or musculoskeletal issues.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Gait Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in nerve function (Phase I)

Changes in nerve function (Phase II)

Changes in stepping reaction time (Phase I)

+3 more

Secondary outcome measures

Fugl-Meyer Lower Extremity Function Assessment (Phase I)

Lower Extremity

Mini-mental State Examination (Phase I)

+1 more

Gait 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

~820

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Texas Woman's UniversityLead Sponsor

86 Previous Clinical Trials

5,700 Total Patients Enrolled

10 Trials studying Stroke

438 Patients Enrolled for Stroke

Shih-Chiao Tseng, PT, PhDPrincipal Investigator - Texas Woman's University School of Physical Therapy

Texas Woman's University

1 Previous Clinical Trials

130 Total Patients Enrolled

1 Trials studying Stroke

130 Patients Enrolled for Stroke

Media Library

Transcranial direct current stimulation (tDCS) (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04437251 — N/A

Stroke Research Study Groups: Effects of brain stimulation on functional improvements, Effects of brain stimulation combined with stepping training, Brain stimulation-induced improvements in leg skill learning

Stroke Clinical Trial 2023: Transcranial direct current stimulation (tDCS) Highlights & Side Effects. Trial Name: NCT04437251 — N/A

Transcranial direct current stimulation (tDCS) (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04437251 — N/A

Stroke Patient Testimony for trial: Trial Name: NCT04437251 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I submit my candidacy for this investigation?

"This trial is accepting 180 candidates between 21 and 90 years of age with spastic lower limb weakness. To qualify, they must be able to walk 10 meters unaided or aided by assistive devices, have no chronic neurological nor musculoskeletal conditions impacting the range of motion in their hips and knees (with ankle dorsiflexion/plantarflexion limited to 10°), stand alone for more than 30 seconds, possess a minimum MMSE score of 24, and vision that can be corrected using glasses or contact lenses up to 20/20 acuity."

Answered by AI

What objectives is this experiment hoping to achieve?

"The aim of this trial is to analyse changes in reaction time prior, during and after a single stimulation session. The primary outcome will be any shift in locomotive performance (Phase I). Additionally, the Mini-Mental State Examination (Phases I & II) which evaluates cognitive function via 11 items with scores from 0 to 30, where 23 or below indicates impairment, and Fugl-Meyer Lower Extremity Function Assessment (Phase I), which examines motor skills at the hip, knee and ankle with sums scoring between 0-34; higher numbers signifying better functioning."

Answered by AI

How many individuals are taking part in the experiment?

"Correct. As evidenced by the information on clinicaltrials.gov, this medical trial is currently seeking applicants; it was first posted in September 2014 and revised last June 2020. A total of 180 patients are needed from a single site."

Answered by AI

Is there an ongoing call to participants for this experiment?

"Indeed, the website clinicaltrials.gov confirms that this research is still recruiting participants. The trial was initially posted on September 26th 2014 and recently modified on June 16th 2020; 180 volunteers are required from 1 medical centre to take part in it."

Answered by AI

Are there any age limitations for potential participants in this clinical experiment?

"This study is accepting participants aged 21 and above, up to 90 years of age."

Answered by AI

Who else is applying?

What state do they live in?

Texas

What site did they apply to?

Texas Woman's University

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Looking for more resources to aid in my stroke recovery. I have an implanted baclofen pump for spastic tetraplegia. I had a mild stroke 2019. I have upper motor neuron syndrome.

PatientReceived 1 prior treatment

Recent research and studies

Clinical Neurophysiology PracticeJournal

Adverse Events of Tdcs and Tacs: A Review

Matsumoto, Hideyuki, and Yoshikazu Ugawa. 2017. “Adverse Events of Tdcs and Tacs: A Review”. Clinical Neurophysiology Practice. Elsevier BV. doi:10.1016/j.cnp.2016.12.003.

clinicaltrials.govStudy

Effect of Brain Stimulation on Stepping Performance in Stroke Survivors and Healthy Adults

Shih-Chiao Tseng 2014. "Effect of Brain Stimulation on Stepping Performance in Stroke Survivors and Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04437251.