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Testing ultrasound brain stimulation settings in people with arm weakness after stroke

Compares ultrasound brain stimulation power and timing settings in adults after stroke.

Plain-language title generated from the registry record
Registry title: Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

Key facts

Where
Durham, United StatesSee the site

Where in United States

  • Duke University HospitalDurham, United StatesTaking people

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Trial details

Who runs it
Duke University
Trial code
NCT07220005
Record updated
27 August 2026
Original description
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.Read full original descriptionShow less

Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

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.

Inclusion: 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: Concurrent enrollment in another interventional stroke recovery study; 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); Bilateral strokes (infarcts and/or hematoma); Presence of any MRI/TMS/LIFUS risk factors; Concerns that the subject cannot comply with study procedures and visits; Pregnant.

ClinicalTrials.gov NCT07220005