Arm Weakness as a Consequence of Stroke, Stroke, Upper Extremity Hemiparesis, Upper Extremity Impairments, Upper Extremity Weakness
Conditions
Keywords
Brain Stimulation, Transcranial Focused Ultrasound Stimulation, Low Intensity Focused Ultrasound Stimulation, Stroke Recovery, Motor Learning, Corticospinal Excitability
Brief summary
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
DEVICELow intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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 resting motor threshold and testing motor threshold recorded from an affected upper extremity 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor sequence learning | 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 | Baseline, immediately after intervention, and 1 hour after intervention. | Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential. |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
CONTACTZiping Huang, MS
PRINCIPAL_INVESTIGATORWayne Feng, MD MS
Duke University
Outcome results
None listed