Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177470
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Effectiveness of Accelerated Deep TMS in OCD
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Effectiveness of Accelerated Transcranial Magnetic Stimulation in Obsessive Compulsive
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
H-coil high-frequency deep transcranial magnetic stimulation dTMS over the medial prefrontal cortex mPFC and anterior cingulate cortex ACC has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder At the same time there are studies in the literature showing the effectiveness of intermittent theta burst stimulation application and the advantages of short treatment duration However there is no strong scientific evidence yet on the effectiveness and safety of iTBS 50 Hz application with a double-cone coil in obsessive-compulsive disorder patients The aim of this study is to evaluate the effectiveness of dTMS with ITBS protocol on the medial prefrontal cortex mPFC and anterior cingulate cortex ACC in OCD patients
Detailed Description:
The current study aimed to investigate the effectiveness and safety of the ITBS protocol which is applied to the mPFC and ACC for 5 sessions per day with a double-cone coil in treatment-resistant OCD patients This study evaluated I the effectiveness of Itbs 50 Hz stimulation of the mPFC and ACC with a double-cone coil and II the effectiveness of administering this protocol over 2 weeks rather than six weeks as approved by the FDA Participants will be randomized into two parallel groups in a double-blind manner In one group ITBS 50 Hz dTMS will be applied to mPFC and ACC and in the other group sham tms will be applied to the same regions The application consists of a total of 50 sessions 5 times a day This application will last for a total of 10 days excluding weekends
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