NCT07220005 · Duke University
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
(LIFUS-OPTIMIZE)
What this study is about
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.
View original scientific description
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
Motor sequence learning (MSL) involves predictive processing that results in the anticipation of each component of a sequence of actions. MSL will produce response times and the MSL measure will be the number of responders (i.e., those with ≥20% reduction in the response time).
Corticospinal excitability
Time frame: Baseline, immediately after intervention, and 1 hour after intervention.
Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations