The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients. (NCT06765642) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.
United States26 participantsStarted 2025-06-09
Plain-language summary
The study is about using a brain stimulation technique called rTMS (Repetitive Transcranial Magnetic Stimulation) to help improve hand muscles in people who had a stroke. Researchers want to understand how this device can help stroke patients use their hands better.
Who can participate
Age range
21 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
. Age \>=21 years old of any race or gender
. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 3 months from stroke onset
. Unilateral arm weakness measured by FM-UM scale \<= 62 out of 66
. Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject
Exclusion criteria
. Bilateral strokes (infarcts and/or hematoma)
. Other co-existent neuromuscular disorders affecting upper extremity motor impairment.
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.
1This trial is comparing three different rTMS stimulation patterns — FiTBS600, FiTBS2400, and DiTBS2400 — to see how they affect brain signals related to hand movement after stroke; given my specific level of hand weakness and how long it's been since my stroke, do you think my situation fits what this study is actually trying to measure?
2Since this trial is listed as Phase NA, meaning it's likely focused on understanding how these brain stimulation techniques work rather than proving a treatment benefit, is it realistic for me to expect any improvement in my hand function by participating, or is this more about contributing to research?
3The study is targeting something called corticospinal excitability in the hand muscle on the side of the brain affected by stroke — can you explain in plain terms what that means for me, and whether changes in that measure would actually translate into anything I'd notice in my daily hand use?
4Are there any risks specific to repetitive transcranial magnetic stimulation that I should know about, especially since this trial is testing multiple stimulation doses and patterns that may not yet have a well-established safety profile in chronic stroke patients like me?
5Before I consider joining this trial, are there standard rehabilitation therapies or other established treatments for post-stroke arm weakness that we haven't fully tried yet, and would it make more sense to pursue those first?
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
To determine whether there is overall stimulation effect among three stimulation paradigms (FiTBS600; FiTBS2400; DiTBS2400) on the ipsilesional corticospinal excitability of a hand muscle.
Timeframe: Baseline, prior to and after intervention (Pre0 and Pre1; 45 minutes apart)
. History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study.
. Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later).
. Presence of any MRI/rTMS risk factors including but not limited to:
. an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.
. a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.
. history of seizure disorder before stroke or seizure after stroke.