Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350396
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-01
Brief Title:
pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
rTMS Intervention for DMPFC Treatment of Treatment-Resistant Depression Under the Guidance of Personalized Brain Functional Area Dissection pBFS Technology
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:
This study is a multicenter randomized double-blind placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression
Detailed Description:
Repetitive transcranial magnetic stimulation rTMS is an established therapy for treatment-resistant depression The dorsomedial prefrontal cortex DMPFC which serves as a connection intermediary of the aberrant functional network in cognitive control and rumination in depression is highly correlated with disease manifestations and post-treatment improvements through several studies involving neuroimaging and brain injury Research has shown that the response of DMPFC to rTMS is more subject to improving the dimensions of anxiety and insomnia in depression Therefore exploring the novel target DMPFC is also beneficial for distinguishing disease dimensions in the future thereby enabling personalized treatment and improving clinical treatment efficacy
After being informed about the study and potential risks All patients giving written informed consent will undergo a screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be randomized double-blind in a 11 ratio to the active rTMS group or sham-control group Then all participants will undergo a 21-day rTMS modulation and a 3-week 9-week and 6-month post-treatment follow-up visit
After being informed about the study and potential risks All patients giving written informed consent will undergo a screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be randomized double-blind in a 11 ratio to the active rTMS group or sham-control group Then all participants will undergo a 21-day rTMS modulation and a 3-week 9-week and 6-month post-treatment follow-up visit
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