Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults

NCT06191549 | Active Not Recruiting

• 1 other identifier: 21-0295
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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

  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.

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

  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.

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

  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.

  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

  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

  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

  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

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

  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

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

  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

  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

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

Study Arms (4)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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

anodal transcranial direct current stimulation (a-tDCS) 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.; To explore the accumulated effects of brain stimulation on gait improvements in stroke survivors; To explore the effect of brain stimulation on locomotor skill acquisition in stroke survivors; To explore the trends of functional improvements after single a-tDCS session in stroke survivors.

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• The Claude D. Pepper Older Americans Independence Centers: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Shih-Chiao Tseng, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to their assigned brain stimulation protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)