Cerebral Vascular AccidentNCT06191549
Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults
A study testing anodal transcranial direct current stimulation (a-tDCS) in people with Cerebral Vascular Accident, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Vascular Accident
- What is being tested?
- anodal transcranial direct current stimulation (a-tDCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Shih-Chiao Tseng, PT, PhD, 409-772-9555
About this study
Official title: Effect of Brain Stimulation on Locomotor Skill Acquisition in Stroke
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.
- Conditions
- Cerebral Vascular Accident
- Being tested
- anodal transcranial direct current stimulation (a-tDCS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: Combination Product: anodal transcranial direct current stimulation (a-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 May 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Vascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- The Claude D. Pepper Older Americans Independence Centers
- Responsible party
- Sponsor
- Investigators
- Shih-Chiao Tseng, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191549
- Sponsor's protocol ID
- 21-0295
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes