Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400407
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Lesion Network Mapping Navigated Continuous Theta-burst Stimulation for Motor Recovery in Acute Ischemic StrokeA Randomized Double-Blind Sham-Controlled Phase 2 Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
MASTRE
Brief Summary:
This is a multicenter sham-controlled double-blind randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke at 3-14 days after onset
Detailed Description:
The target population of this study was patients with acute ischemic stroke Lesion network mapping and navigation were used to select individual stimulation targets Enrolled patients were randomly assigned in a 11 ratio to the cTBS group or the Sham stimulation group and received
cTBS group Based on the map an 8-shaped coil was used to stimulate the motor function-related targets The stimulation intensity was RMT80 600 pulses 50Hz 40s per target and the stimulation interval was more than 2 hours The total course of treatment lasted 7 days
Sham stimulation group A Sham stimulation coil was used to stimulate based on the map The sound and duration were the same as the cTBS group ensuring no effective stimulation The total course of treatment lasted 7 days
cTBS group Based on the map an 8-shaped coil was used to stimulate the motor function-related targets The stimulation intensity was RMT80 600 pulses 50Hz 40s per target and the stimulation interval was more than 2 hours The total course of treatment lasted 7 days
Sham stimulation group A Sham stimulation coil was used to stimulate based on the map The sound and duration were the same as the cTBS group ensuring no effective stimulation The total course of treatment lasted 7 days
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?:
False
Is an FDA AA801 Violation?:
None