Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964062
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-11
Brief Title:
pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
Personalized Brain Functional Sectors pBFS Guided High-dose rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder A Randomized Double-Blind Sham-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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 research aims to evaluate the safety and efficacy of pBFS-guided High-dose rTMS therapy targeting preSMA for patients with treatment-resistant Obsessive-Compulsive Disorder
Detailed Description:
In 2018 rTMS received approval from the US Food and Drug Administration FDA for the treatment of OCD Based on a systematic meta-analysis of randomized clinical trials researchers compared the efficacy of different intervention targets DMPFC DLPFC OFC SMA and found that targeting the anterior part of the right SMA in patients yielded the best response rates for individuals with obsessive-compulsive disorder OCD while targeting the DLPFC showed poor efficacy However the preSMA is a large region and different nodes within this region have distinct functional connections with other areas Thus precise localization of neural circuitry implicated in OCD symptomatology is essential for achieving effective therapeutic interventions Leveraging an innovative technique pBFS the current study aims to identify individual-specific preSMA targets with functional connectivity to the attention network enabling a more personalized and targeted approach to diagnosis and treatment for OCD patients A novel high-dose treatment modality known as SAINT received approval from the US FDA in September 2022 for managing the treatment-resistant major depressive disorder Building upon these findings this study hypothesizes that high-dose iTBS targeting the preSMA guided by pBFS will have a significant therapeutic effect on clinical symptoms in treatment-resistant OCD patients
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 in a double-blind manner in a 21 ratio to the active rTMS group or sham-control group Then all participants will undergo a 5-day rTMS modulation and a 1-month 2-month 3-month follow-up visit Patients will have a stable treatment regimen during the 5-day treatment and one-month post-treatment
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 in a double-blind manner in a 21 ratio to the active rTMS group or sham-control group Then all participants will undergo a 5-day rTMS modulation and a 1-month 2-month 3-month follow-up visit Patients will have a stable treatment regimen during the 5-day treatment and one-month post-treatment
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