Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842304
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-04-24
Brief Title:
Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke a Multi-center RCT
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
Personalized Brain Functional Sectors pBFS-Guided rTMS Intervention for Aphasia After Ischemic Stroke a Multi-center Randomized Parallel Controlled Study
Status:
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:
None
Brief Summary:
The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic stroke aphasic patients
Detailed Description:
Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases including treating post-stroke symptoms Using the personalized brain functional sectors pBFS technique we could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data The current study proposes to conduct a multi-center double-blinded randomized and parallel controlled design trial to investigate the efficacy and safety of pBFS-guided personalized TMS intervention in post-stroke aphasic patients
Subjects will be randomly assigned to the following two groups active continuous TBS cTBS group or a sham control group The allocation ratio will be 21 Subjects will receive a 3-week treatment for 21 consecutive days The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision
Subjects will be randomly assigned to the following two groups active continuous TBS cTBS group or a sham control group The allocation ratio will be 21 Subjects will receive a 3-week treatment for 21 consecutive days The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision
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