The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.
Recruiting
N/AInterventional Study
StrokeStroke PatientsArm Weakness as a Consequence of StrokeBrain StimulationTranscranial Magnetic Stimulation RepetitiveTranscranial Magnetic StimulationMotor LearningChronic Stroke PatientsChronic Stroke Survivors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
26 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for people who have had their first stroke at least 3 months ago and have weakness in one arm. Participants will receive a brain stimulation treatment to see if it helps improve their hand muscle function.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 21 years old
I have had my first stroke at least 3 months ago
I have weakness in one arm
I can participate in testing my muscle response
You may not be able to join if
I have had strokes on both sides of my brain
I have another disorder affecting my arm movement
I have uncontrolled depression or other serious mental health issues
I have high blood pressure that isn't controlled
I have any medical devices in my body that could be affected
I have had seizures before or after my stroke
I am currently in another stroke recovery study
I am pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion criteria:
1. Age \>=21 years old of any race or gender
2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 3 months from stroke onset
3. Unilateral arm weakness measured by FM-UM scale \<= 62 out of 66
4. Inducible rest motor threshold and testing motor threshold…
Inclusion criteria:
1. Age \>=21 years old of any race or gender
2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 3 months from stroke onset
3. Unilateral arm weakness measured by FM-UM scale \<= 62 out of 66
4. Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject
Exclusion criteria
1. Bilateral strokes (infarcts and/or hematoma)
2. Other co-existent neuromuscular disorders affecting upper extremity motor impairment.
3. 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.
4. 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).
5. Presence of any MRI/rTMS risk factors including but not limited to:
1. an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.
2. a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.
3. history of seizure disorder before stroke or seizure after stroke.
4. preexisting scalp lesion or bone defect or hemicraniectomy.
6. Concurrent enrollment in another interventional stroke recovery study.
7. Concerns that the subject cannot comply with study procedures and visits.
8. Pregnant individuals
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