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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Experimental | Participant will receive ultrasound stimulation at intensity of 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA). |
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| ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Experimental | Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm^2 |
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| Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Sham Comparator | Participant will receive ultrasound stimulation at ISPPA- 0 W/cm^2 or sham stimulation |
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| Pulse repetition frequency(PRF) at 2000 Hz | Experimental | each participant will receive LIFUS with pulse repetition frequency at 2000 Hz |
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| Pulse repetition frequency(PRF) at 1000 Hz | Experimental | each participant will receive LIFUS with pulse repetition frequency at 1000 Hz |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity focused ultrasound stimulation | Device | A low-intensity focused ultrasound stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, immediately after intervention, and 1 hour after intervention |
| Corticospinal excitability | Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential. | Baseline, immediately after intervention, and 1 hour after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | 919-668-7597 | megan.gonzalez@duke.edu | |
| Ziping Huang, MS | Contact | ziping.huang@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wayne Feng, MD MS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
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|
| Pulse repetition frequency (PRF) at 500 Hz | Experimental | Participants will receive LIFUS with pulse repetition frequency at 500 Hz |
|
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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