Status:
RECRUITING
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Lead Sponsor:
Duke University
Conditions:
Stroke
Arm Weakness as a Consequence of Stroke
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
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 rest motor threshold and testing motor threshold recorded from the affected abductor pollicis brevis muscle
Exclusion
- 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
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07220005
Start Date
December 10 2025
End Date
June 30 2026
Last Update
December 23 2025
Active Locations (1)
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1
Duke University Hospital
Durham, North Carolina, United States, 27710