Actively Recruiting
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Led by Duke University · Updated on 2025-12-23
24
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Clinical Research Coordinator
CONTACT
Z
Ziping Huang, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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