Recruiting

tDCS

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06191549

Conditions

Cerebral Vascular Accident

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

anodal transcranial direct current stimulation (a-tDCS)

Study Details

Brief 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.

Conditions

Cerebral Vascular Accident

Study ID

NCT06191549

Start date

May 1, 2025

Status verified date

Oct, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

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.

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.

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.

Interventions

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

Primary outcome measure

  • Mean change from baseline in stepping motor control after a single brain stimulation and locomotor learning session. [ Time Frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session ]
  • Mean change from baseline in gait performances after a single brain stimulation and locomotor learning session. [ Time Frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session ]
  • Mean change from baseline in brain neuronal network activations after a single brain stimulation and locomotor learning session. [ Time Frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session ]
  • Mean change from baseline in brain neuronal activations after a single brain stimulation and locomotor learning session. [ Time Frame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session ]
  • Mean change from baseline in stepping motor control after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training [ Time Frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training ]
  • Mean change from baseline in gait performances after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training [ Time Frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training ]
  • Mean change from baseline in brain neuronal network activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training [ Time Frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training ]
  • Mean change from baseline in brain neuronal activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training [ Time Frame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training ]

Central Contacts and Locations

Central contacts

Shih-Chiao Tseng, PhD

409-772-9555shtseng@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Shih-Chiao Tseng, PT, PhD

409-772-9555

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.