Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults

NCT ID: NCT06191549

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-08-31

Brief Summary

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Recent studies showed that a non-invasive, low-intensity brain stimulation called transcranial direct current stimulation (tDCS) can effectively increase motor neuron excitability in the brain and therefore promotes functional recovery after stroke. Thus, the overall purpose of this research project is to examine the effect of brain stimulation on motor skill learning in stroke survivors.

Detailed Description

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The specific aims and hypotheses are:

Aim 1: To explore the trends of locomotor skill acquisition in stroke survivors after anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after sham tDCS (s-tDCS), and stroke with no brain stimulation (control; CON). Hypothesis (Aim 1): Stroke participants who receives a-tDCS will show a faster rate of learning a locomotor task compared to stroke participants who receive s-tDCS and stroke participants with no brain stimulation.

Aim 2: To explore different trends of stimulation-induced improvements in learning capacity and neural activities between three groups: stroke group, healthy young group, and healthy older group. Hypothesis (Aim 2): Healthy young adults will have a greater degree of stimulation-induced improvements in learning capacity and neural excitation compared to older adults and stroke participants.

Aim 3: To explore the trends of functional improvements post a-tDCS in stroke survivors. Hypothesis (Aim 3): Stroke participants who receives a-tDCS will show a greater improvements in functional performances compared to stroke participants who receive s-tDCS and stroke participants with no brain stimulation.

Aim 4: To explore the accumulated, longitudinal trends of a four-week visuomotor stepping training in conjunction with brain stimulation on treadmill walking training and gait improvements for persons with chronic stroke. Hypothesis (Aim 4): Stroke participants who receives a-tDCS will show a greater degree of gait improvements compared to stroke participants who receive s-tDCS and stroke participants with no brain stimulation.

Conditions

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Cerebral Vascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and outcome assessors will be blinded to their assigned brain stimulation protocols.

Study Groups

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To explore the effect of brain stimulation on locomotor skill acquisition in stroke survivors

To explore the trends of locomotor skill acquisition in stroke survivors after anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after sham tDCS (s-tDCS), and stroke with no brain stimulation (control; CON).

Group Type EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type COMBINATION_PRODUCT

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training

To explore improvements in learning capacity between healthy adults and stroke participants.

Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group.

Group Type EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type COMBINATION_PRODUCT

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training

To explore the trends of functional improvements after single a-tDCS session in stroke survivors.

To explore functional improvements (gait performance, brain neural activation) between a-tDCS, s-tDCS, and control groups.

Group Type EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type COMBINATION_PRODUCT

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training

To explore the accumulated effects of brain stimulation on gait improvements in stroke survivors

To explore the accumulated, longitudinal trends of a four-week visuomotor stepping training in conjunction with brain stimulation on treadmill walking training and gait improvements for persons with chronic stroke.

Group Type EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type COMBINATION_PRODUCT

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training

Interventions

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anodal transcranial direct current stimulation (a-tDCS)

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Age between 21 and 90 years
* Medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment
* MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract
* Hemiparesis involving the lower extremity (Fugl-Meyer Lower Extremity Motor Test)
* No passive range of motion limitation in bilateral hips and knees
* Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less
* Visual acuity can be corrected by glasses or contact lens to 20/20
* Able to walk independently with/without assistant devices for 10 meters
* Able to maintain standing position without any assistance \>= 30 sec (Short Physical Performance Battery)
* Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24

Exclusion Criteria

* Pregnant women
* MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or tumors
* Have any metal implants, cardiac pacemakers, or history of seizures
* Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training
* Any vestibular dysfunction or unstable angina
* Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Claude D. Pepper Older Americans Independence Centers

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shih-Chiao Tseng, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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21-0295

Identifier Type: -

Identifier Source: org_study_id

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