NCT07220005 Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
| NCT ID | NCT07220005 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-12-10 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 rest motor threshold and testing motor threshold recorded from the affected abductor pollicis brevis 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
Contact & Investigator
Wayne Feng, MD MS
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07220005 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07220005 currently recruiting?
Yes, NCT07220005 is actively recruiting participants. Contact the research team at megan.gonzalez@duke.edu for enrollment information.
Where is the NCT07220005 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07220005 clinical trial?
NCT07220005 is sponsored by Duke University. The principal investigator is Wayne Feng, MD MS at Duke University. The trial plans to enroll 24 participants.
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