Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391086
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-25
Brief Title:
Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Transcranial focused ultrasound tFUS can be used as a non-invasive brain neuromodulation technique Low-intensity focused ultrasound has been demonstrated to be safe and have neuromodulatory effects on the cerebral cortex in healthy human and animal experimentsThis study aims to investigate the effect of tFUS on cortical excitability for motor recovery in patients with stroke
Detailed Description:
The study is a pilot study for feasibility which aims to recruit 20 patients with subacute within 3 months stroke and unilateral hemiparesis tFUS stimulation will be delivered The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex as well as safety analysis the secondary outcome measures include the Fugl-Meyer Assessment Medical Research Council score National Institutes of Health Stroke Scale NIHSS Barthel Index Modified Rankin Scale and functional brain activities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None