The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.

Launched by DUKE UNIVERSITY · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called repetitive transcranial magnetic stimulation, or rTMS, to see if it can help improve hand strength and movement in people who have had a stroke. The researchers believe that this non-invasive brain stimulation technique may help stroke survivors use their hands better, which can enhance their daily activities and overall quality of life.

To participate in the study, individuals must be at least 21 years old and have experienced their first stroke at least six months ago, which has caused weakness in one arm. Those who have had multiple strokes or have certain other medical conditions may not be eligible. If selected, participants can expect to receive rTMS treatment in a safe environment while being monitored by medical professionals. This trial is not yet recruiting, so there will be more information available in the future for those interested in joining.

Gender

ALL

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 6 months from stroke onset
• • 3. Unilateral arm weakness measured by FM-UM scale \<= 62/64
• • 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. History of confirmed dementia or taking the following dementia drugs, such as Donepezil, Rivastigmine, Galantamine, Memantine, Aducanumab, Lecanemab, Donanemab that affecting their ability to follow study procedure.
• • 5. 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).
• 6. 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.