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Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

RecruitingNAAges 21 Years - anyAllDuke University
NCT07220005 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions. * with increasing power, would LIFUS be more effective? * with the same power, what LIFUS timing is the best For Aim 1, the study will compare 8, 4 W/cm\^2 to a zero(sham) stimulation to see if higher power is the better. For Aim 2, the study will compare 500 vs 1000 vs 2000 Hz "timing" to see which one is better.

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📋 Eligibility rules (as published)
Inclusion Criteria: * age \>=21 years old of any gender or race * First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms * Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64 * Inducible resting motor threshold and testing motor threshold recorded from an affected upper extremity muscle Exclusion Criteria: * Bilateral strokes (infarcts and/or hematoma) * Other co-existent neuromuscular disorders affecting upper extremity motor impairment * 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 * History of confirmed dementia or taking dementia drugs * Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and enrolled later) * Presence of any MRI/TMS/LIFUS risk factors * Concurrent enrollment in another interventional stroke recovery study * Concerns that the subject cannot comply with study procedures and visits * Pregnant
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What it tests

  • Low intensity focused ultrasound stimulation
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Where

1 site
Duke University Hospital
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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