Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
NCT ID: NCT07220005
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-12-10
2026-06-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at intensity of 8 W/cm\^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).
Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm\^2
Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at ISPPA- 0 W/cm\^2 or sham stimulation
Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Pulse repetition frequency(PRF) at 2000 Hz
each participant will receive LIFUS with pulse repetition frequency at 2000 Hz
Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Pulse repetition frequency(PRF) at 1000 Hz
each participant will receive LIFUS with pulse repetition frequency at 1000 Hz
Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Pulse repetition frequency (PRF) at 500 Hz
Participants will receive LIFUS with pulse repetition frequency at 500 Hz
Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Interventions
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Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Wayne Feng, MD MS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Hospital
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Megan Gonzalez, MS
Role: primary
Other Identifiers
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Pro00117400
Identifier Type: -
Identifier Source: org_study_id