NCT02479906

A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Brainsway · Industry
• Sex: All
• Age: 22 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	Deep TMS System	Deep TMS treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions.
DEVICE	Sham Treatment	Sham treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions

Timeline

• Start date: 2016-11-17
• Primary completion: 2020-02-06
• Completion: 2020-03-31
• First posted: 2015-06-24
• Last updated: 2020-05-14

Locations

15 sites across 3 countries: United States, Canada, Israel