A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
NCT02479906 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2020-05-14
Summary
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.
Conditions
- Post-Traumatic Stress Disorder
Interventions
- 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
Sponsors & Collaborators
-
Brainsway
lead INDUSTRY
Principal Investigators
-
Moshe Isserles, MD · Hadassah Ein Karem Medical Center and Center for Addiction and Mental Health (CAMH)
-
Zafiris J. Daskalakis, MD · Center for Addiction and Mental Health (CAMH)
-
Avraham Zangen, PhD · Ben-Gurion University of the Negev
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Max Age
- 68 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-17
- Primary Completion
- 2020-02-06
- Completion
- 2020-03-31
Countries
- United States
- Canada
- Israel
Study Locations
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