Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964049
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-10
Brief Title:
pBFS Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
Personalized Brain Functional Sectors pBFS Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder A Randomized Double-Blind Sham-controlled Trial
Status:
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 investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DLPFC 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 randomized clinical trials researchers have observed significant variations in the intervention effects when targeting the dorsolateral prefrontal cortex DLPFC which is a large region with different subregions and functional connections to other areas across multiple functional networks Precise targeting of neural circuitry related to OCD symptoms is crucial for effective intervention The ventrolateral prefrontal cortex and insula are key components of the OCD functional circuitry within the ventral attentionsalience network However stimulating these brain regions with TMS is challenging and patients often have a low tolerance Previous studies have found that effective targets for various interventions used in psychiatric disorders are located within the same functional circuitry Therefore in this study The investigator employed the pBFS technique to precisely locate the DLPFC subregions within the ventral attentionsalience network The investigator hypothesizes that rTMS intervention targeting the DLPFC guided by pBFS will significantly alleviate 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 15-day 3 weeks treatment on weekdays rTMS modulation After treatment 15- 30- 60- and 90-day follow-up visits will occur Participants will keep a stable treatment regimen during the intervention and the first-month follow-up
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 15-day 3 weeks treatment on weekdays rTMS modulation After treatment 15- 30- 60- and 90-day follow-up visits will occur Participants will keep a stable treatment regimen during the intervention and the first-month follow-up
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