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
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