Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 6:24 PM
Study NCT ID:
NCT05404360
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Long Term Efficacy and Durability of the BrainsWay Deep TMS in OCD Subjects
Sponsor:
Brainsway
Organization:
Study Overview
Official Title:
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
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:
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Detailed Description:
The study is a randomized, double-blind, multi-center trial comparing active Deep TMS treatment to sham treatment over the course of the trial. The treatment phase will consist of 44 treatments over thirteen weeks. The acute treatment phase will consist five daily treatments over the course of six weeks, followed by twice weekly continuation treatments for seven weeks. Responders will be eligible to enter the durability phase. For assessment of durability, responders will be assessed quarterly for up to one year from the end of the treatment phase.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: