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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Device: Deep TMS System
* Device: Sham Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Treatment<br>In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain. | Device: Sham Treatment<br>* 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<br>|
| Experimental: Deep TMS System<br>Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The HAC Coil is designed to stimulate neuronal pathways in the medial prefrontal cortex or motor cortex, including the anterior cingulated cortex. | Device: Deep TMS System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS-5 Score | CAPS-5 Score measured by change from baseline. | 5 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Response rate at the 5 week follow-up visit. | 5 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Traumatic Stress Disorder, PTSD, dTMS