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

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post-Traumatic Stress Disorder, PTSD, dTMS Read More

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.