for people ages 22-68 (full criteria)
at San Diego, California and other locations
study started
estimated completion:
David Feifel



The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.

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)


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.


Post-Traumatic Stress Disorder PTSD dTMS Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Deep TMS System Sham Treatment


You can join if…

Open to people ages 22-68

  • Outpatients
  • Men and women 22-68 years of age
  • Subjects currently diagnosed with PTSD according to the DSM-5, using the CAPS-5(past-month version), with the following criteria met:
  • Criterion B: at least 1/5 intrusion symptoms; and
  • Criteria C: at least 1/2 avoidance symptoms; and
  • Criteria D: at least 2/7 cognition & mood symptoms; and
  • Criteria E: at least 2/6 arousal & reactivity symptoms; and
  • Criterion F: duration is met; and
  • Criteria G: distress is met.
  • Subjects with at least moderate PTSD with a CAPS-5 score ≥ 25 at both Screening and Baseline visits.
  • Subjects with an HDRS-21 score ≤ 26 at both Screening and Baseline visits.
  • Subjects with negative or mitigated answers on safety screening questionnaire for transcranial magnetic stimulation.
  • Negative pregnancy test in childbearing age women.
  • Subject is capable and willing to provide informed consent.
  • Subject is able to adhere to the treatment schedule.

You CAN'T join if...

  • Subject diagnosed according to the SCID I as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when HDRS-21≤26).
  • Subjects diagnosed according to the SCID II as suffering from Severe Personality Disorder.
  • Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.
  • Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
  • Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.
  • Subject has a history of cranial surgery.
  • Subject has metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators,intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants,or electrodes) or implanted medical pumps.
  • Subject has severe and frequent headaches.
  • Subject has a history of significant hearing loss.
  • Subjects with a significant neurological disorder or insult including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion
  • History of cerebrovascular accident
  • Transient ischemic attack within two years
  • Cerebral aneurysm
  • MMSE ≤ 24
  • Parkinson's disease
  • Huntington's chorea
  • Multiple sclerosis
  • Subject with a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
  • Inadequate communication with the patient.
  • Subject is under custodial care.
  • Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
  • Subject with unstable physical disease such as unstable cardiac disease.
  • Subject is currently on Benzodiazepine at a dose higher than 3 mg of Lorazepam or equivalent.
  • Subject has had previous treatment with TMS.
  • Women who are breast-feeding.
  • Women of childbearing potential and not using a medically accepted form of contraception when sexually active.


  • University of California - San Diego Medical Center accepting new patients
    San Diego California 92103 United States
  • Kadima Neuropsychiatry accepting new patients
    San Diego California United States

Lead Scientist


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