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Active, not recruitingNCT06191549Updated Oct 31, 2025

Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults

An interventional study of anodal transcranial direct current stimulation (a-tDCS) in Cerebral Vascular Accident, sponsored by The University of Texas Medical Branch, Galveston. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-31.

Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
21 Years to 90 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Cerebral Vascular Accident

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    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).

    Combination Product: anodal transcranial direct current stimulation (a-tDCS)

  • Experimental
    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.

    Combination Product: anodal transcranial direct current stimulation (a-tDCS)

  • Experimental
    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.

    Combination Product: anodal transcranial direct current stimulation (a-tDCS)

  • Experimental
    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.

    Combination Product: anodal transcranial direct current stimulation (a-tDCS)

Interventions

  • Combination productanodal 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

06

What researchers measure

Primary outcomes

  1. Mean change from baseline in stepping motor control after a single brain stimulation and locomotor learning session.

    stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen

    Time frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session

  2. Mean change from baseline in gait performances after a single brain stimulation and locomotor learning session.

    Gait performances will be quantified by gait speed (meters/second) during ground walking tests

    Time frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session

  3. Mean change from baseline in brain neuronal network activations after a single brain stimulation and locomotor learning session.

    The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes.

    Time frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session

  4. Mean change from baseline in brain neuronal activations after a single brain stimulation and locomotor learning session.

    The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations

    Time frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session

  5. Mean change from baseline in stepping motor control after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training

    stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen

    Time frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training

  6. Mean change from baseline in gait performances after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training

    Gait performances will be quantified by gait speeds (meters/second) during ground walking tests

    Time frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training

  7. Mean change from baseline in brain neuronal network activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training

    The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes

    Time frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training

  8. Mean change from baseline in brain neuronal activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training

    The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations

    Time frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training

07

Study locations

1 site
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06191549
Lead sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Claude D. Pepper Older Americans Independence Centers
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
May 1, 2025
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Oct 31, 2025

Study contacts

Shih-Chiao Tseng, PhD
principal investigator · University of Texas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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