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NCT07220005Recruiting

Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

Source: ClinicalTrials.gov · Last updated 27 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
24 (estimated)
First submitted
21 Oct 2025
Start date
10 Dec 2025
Primary completion date
30 Sept 2028
Lead sponsor
Duke University
Diseases
Stroke
NCT number
NCT07220005

What you commit to

  • Study type: Interventional
  • Planned participants: 24
  • From 10 Dec 2025 to the primary completion date, 30 Sept 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent enrollment in another interventional stroke recovery study

Other illness

  • 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)

Other

  • Bilateral strokes (infarcts and/or hematoma)
  • Presence of any MRI/TMS/LIFUS risk factors
  • Concerns that the subject cannot comply with study procedures and visits
  • Pregnant

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Hospital
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.