About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Low intensity focused ultrasound stimulation
DeviceA low-intensity focused ultrasound stimulation
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Motor sequence learning
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
Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.
Sponsors and contacts
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