Optimizing low-intensity focused ultrasound to improve arm movement after stroke
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
This research will try low-intensity focused ultrasound on the motor cortex to see if different power levels and timing improve arm strength and motor learning in people at least six months after a first stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07220005 on ClinicalTrials.gov |
What this trial studies
This interventional study delivers low-intensity transcranial focused ultrasound (LIFUS) to the motor cortex of chronic stroke survivors with unilateral upper-extremity weakness to identify stimulation settings that alter cortical excitability and motor learning. In Aim 1 participants receive 8 W/cm^2, 4 W/cm^2, or sham stimulation to test the effect of power, and in Aim 2 the study compares pulse timing at 500, 1000, and 2000 Hz at the same power to determine optimal timing. Primary outcomes include changes in cortical excitability (motor thresholds) and performance on motor-learning tasks. All procedures are conducted at Duke University Hospital and require in-person visits.
Who should consider this trial
Good fit: Adults aged 21 and older who are at least six months from a first ischemic or hemorrhagic stroke, have unilateral upper-extremity weakness (Fugl-Meyer ≤62), and measurable motor thresholds are ideal candidates.
Not a fit: Patients with bilateral strokes, other neuromuscular disorders affecting the arm, uncontrolled hypertension, dementia, or unstable neuropsychiatric conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, identifying optimal LIFUS settings could enhance brain plasticity and lead to better therapies for arm recovery after stroke.
How similar studies have performed: LIFUS neuromodulation has shown promising effects on cortical excitability in animal models and some healthy-volunteer studies, but clinical evidence in stroke patients is limited and this parameter-optimization approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Wayne Feng, MD MS — Duke University
- Study coordinator: Clinical Research Coordinator
- Email: megan.gonzalez@duke.edu
- Phone: 919-668-7597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.