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RECRUITING Not applicable ClinicalTrials.gov

Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07220005

Registry updated: 2026-08-27
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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. * 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.

Interventions

  • Low intensity focused ultrasound stimulation (Device)
    A low-intensity focused ultrasound stimulation

Eligibility criteria

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

Conditions

Stroke Arm Weakness as a Consequence of Stroke Upper Extremity Hemiparesis Upper Extremity Impairments Upper Extremity Weakness

Locations

  • Duke University Hospital — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record