Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077370
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2023-09-27
Brief Title:
dTMS in Obsessive Compulsive Disorder
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Effectiveness of Deep Transcranial Magnetic Stimulation to Medial Prefrontal Cortex and Anterior Cingulate Cortex in Obsessive-Compulsive Disorder Patients
Status:
COMPLETED
Status Verified Date:
2023-10
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:
High-frequency deep transcranial magnetic stimulation dTMS over the medial prefrontal cortex mPFC and the anterior cingulate cortex ACC with an H-coil has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder OCD However there is not yet strong scientific evidence concerning the efficacy and safety of performing a similar procedure with a double-cone coil or in an accelerated manner The aim of this study was evaluating the efficacy of dTMS over the medial prefrontal cortex mPFC and the anterior cingulate cortex ACC in an accelerated manner with double-cone coil
Detailed Description:
The current study aimed to investigate the efficacy and safety of multiple deep stimulations per day with a double-cone coil to the mPFC and ACC in treatment-resistant patients with OCD This study evaluated I the effectiveness of high-frequency stimulation of the mPFC and ACC with a double cone coil and II the effectiveness of the application of this protocol in three weeks not six weeks as approved by the FDA The participants were randomized into two parallel groups in a double-blind manner High frequency 20 Hz dTMS was applied to the mPFC and ACC in one group and sham dTMS to the same regions in the other group twice a day for a total of 30 sessions This application was for three weeks in total 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