Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke… (NCT07599774) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments
United States16 participantsStarted 2026-07-01
Plain-language summary
Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation. Stimulating the brain can improve its function and help with recovery after a stroke. It has been a challenge to do this non-invasively. This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside. In previous research, investigators found that optimal type and target of tDCS varied among subjects. The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy. Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research. The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks. Outcome measures will be collected at the baseline and right after the final intervention session. The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment. The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must be 18 years or older
* Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary.
* Must have substantial motor impairment of the paretic upper limb
* Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb
* Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment)
* Fugl-Meyer Upper Extremity Score of 8-50 based on assessment performed during the baseline visit.
* Must have had either MRI or CT of the brain performed at Carle as part of their stroke care. Imaging may have been performed either during the diagnostic work-up for stroke or as follow-up after diagnosis. The most recent images from either MRI or CT will be collected for this study.
* Capacity to provide informed consent and participate in English (Since this study is a clinical trial and the team is yet to provide the translation service at this stage, the study is restricted to those who can consent and participate in English only).
* Must be willing and able to perform study procedures
Exclusion Criteria:
* Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire
* Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device
* Has metal implants in the head and/or brain
* Presence of muscle tone abnormalities and motor or sensory impairment in the no…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Fugl-Meyer Upper Extremity score from baseline
Timeframe: Right after the final intervention session