A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
a study on Post-Traumatic Stress Disorders
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of 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)
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 DisorderPTSDdTMSDiseaseStress Disorders, TraumaticStress Disorders, Post-TraumaticDeep TMS SystemSham Treatment
You can join if…
Open to people ages 22-68
- 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 DiegoCalifornia92103United States
- Kadima Neuropsychiatry
accepting new patients
San DiegoCaliforniaUnited States
Lead Scientist at UCSD
- accepting new patients
- Start Date
- Completion Date
- Study Type
- Last Updated
Please contact me about this study
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The study team should get back to you in a few business days.