Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT07220005
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFUS-OPTIMIZE
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: