Ignite Creation Date:
2024-05-06 @ 7:06 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02479906
Status:
TERMINATED
Last Update Posted:
2020-05-14
First Post:
2015-06-15
Brief Title:
A Safety Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder PTSD
Sponsor:
Brainsway
Organization:
Brainsway
Study Overview
Official Title:
A Prospective Double Blind Randomized Controlled Study to Evaluate the Safety and Efficacy of the Brainsway HAC-Coil Deep Transcranial Magnetic Stimulation DTMS System for the Treatment of Post-Traumatic Stress Disorder PTSD
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The results did not demonstrate sufficient clinical benefit induced specifically by the active treatment to justify continuation of the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS DTMS for the treatment of PTSD
Detailed Description:
Deep TMS in conjunction with brief trauma exposure will be compared to sham treatment in conjunction with brief trauma exposure in a multicenter randomized controlled study for the treatment of PTSD Study duration is 9 weeks consisting of 4 weeks of treatment and a 5 week and 9 week follow-up visit Subjects will be randomized to real or sham treatment stratified by site The design is meant to demonstrate that the device shows superiority compared to sham treatment at the 5 week follow-up visit and at the 9 week follow-up visit 1 month post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None