StrokeNCT06681207
Explore the Effects of Cortical Priming on Visuomotor Stepping Learning in Persons With Chronic Stroke
A study testing anodal transcranial direct current stimulation (a-tDCS) in people with Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- 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
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (Fulg-Meyer LE 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 malignant neoplasm 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
Physical Therapy, University of Texas Medical Branch
Galveston, Texas, 77555
Shih-Chiao Tseng, PT, PhD, 409-772-9555, shtseng@utmb.edu
About this study
Official title: An Exploratory Study: The Effects of Cortical Priming on Visuomotor Stepping Learning in Healthy Adults and Persons With Chronic Stroke
This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.
- Conditions
- Stroke
- Being tested
- anodal transcranial direct current stimulation (a-tDCS)
- Keywords
- adult, chronic stroke
- 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). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
| Study group | Role | What they receive |
|---|---|---|
| Explore the effects of brain stimulation on locomotor skill learning in stroke survivors | Experimental | To explore the trends of locomotor skill learning in three groups: stroke survivors after five sessions of anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after five sessions of sham tDCS (s-tDCS), and stroke survivors with no brain stimulation (control; CON). Receives: Combination Product: anodal transcranial direct current stimulation (a-tDCS) |
| determine the effects of a-tDCS on the cortical excitation before and after locomotor learning | Experimental | measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants. 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 five tDCS session in stroke survivors | Experimental | Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation. 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 five sessions of brain stimulation combined with visuomotor stepping learning
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 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Mean change from baseline in brain neuronal activations after five sessions of brain stimulation combined with visuomotor stepping learning
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 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Secondary outcomes (2)
Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning
LE motor function will be quantified by Fugl-Meyer LE motor test, Short Physical Performance Battery (SPPB), and gait speed (meters/second) during ground walking tests.
Measured: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Mean change from baseline in brain neuronal network activations after five sessions of brain stimulation combined with visuomotor stepping learning
The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes
Measured: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start23 Apr 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Shih-Chiao Tseng, PT, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681207
- Sponsor's protocol ID
- 24-0234
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study: The Effects of Cortical Priming on Visuomotor Stepping Learning in Healthy Adults and Persons With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06681207
- Acronym / sponsor ID
- 24-0234
- Conditions
- Stroke
- Keywords
- adult, chronic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Explore the effects of brain stimulation on locomotor skill learning in stroke survivors | Experimental | Combination Product: anodal transcranial direct current stimulation (a-tDCS)To explore the trends of locomotor skill learning in three groups: stroke survivors after five sessions of anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after five sessions of sham tDCS (s-tDCS), and stroke survivors with no brain stimulation (control; CON). |
| determine the effects of a-tDCS on the cortical excitation before and after locomotor learning | Experimental | Combination Product: anodal transcranial direct current stimulation (a-tDCS)measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants. |
| To explore improvements in learning capacity between healthy adults and stroke participants. | Experimental | Combination Product: anodal transcranial direct current stimulation (a-tDCS)Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group. |
| To explore the trends of functional improvements after five tDCS session in stroke survivors | Experimental | Combination Product: anodal transcranial direct current stimulation (a-tDCS)Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 (Fulg-Meyer LE motor test)
- No passive range of motion limitation in bilateral hips and knees
Key exclusion criteria (6 listed)
- 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 malignant neoplasm 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups. | Combination product | Explore the effects of brain stimulation on locomotor skill learning in stroke survivors, To explore improvements in learning capacity between healthy adults and stroke participants., To explore the trends of functional improvements after five tDCS session in stroke survivors, determine the effects of a-tDCS on the cortical excitation before and after locomotor learning |
Primary outcome
Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning
Time frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping 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.
Mean change from baseline in brain neuronal activations after five sessions of brain stimulation combined with visuomotor stepping learning
Time frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping 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
2 secondary outcomes
Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning
Time frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Mean change from baseline in brain neuronal network activations after five sessions of brain stimulation combined with visuomotor stepping learning
Time frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shih-Chiao Tseng, PT, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal transcranial direct current stimulation (a-tDCS) in people with Stroke, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chiao Tseng, PT, PhD (409--772-9555, shtseng@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning (time frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.