Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low intensity focused ultrasound stimulation.
- Who it may be relevant to
- Registry conditions: Stroke, Arm Weakness as a Consequence of Stroke, Upper Extremity Hemiparesis, Upper Extremity Impairments. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Primary outcome measures
- Motor sequence learning [Time frame: Baseline, immediately after intervention, and 1 hour after intervention]
- Corticospinal excitability [Time frame: Baseline, immediately after intervention, and 1 hour after intervention.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Hospital — Durham
Identifiers
NCT: NCT07220005 · Pro00117400