The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
203
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.
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
CalNeuro Research Group
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
CAPS-5 Score
CAPS-5 Score measured by change from baseline.
Time frame: 5 weeks from baseline
Response Rate
Response rate at the 5 week follow-up visit.
Time frame: 5 weeks from baseline
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University of California - San Diego Medical Center
San Diego, California, United States
Kadima Neuropsychiatry
San Diego, California, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States
Advanced Mental Health Care Inc.-Palm Beach
Palm Beach, Florida, United States
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States
Yellowbrick Foundation
Evanston, Illinois, United States
TMS Hope Center of Long Island
New York, New York, United States
...and 5 more locations