A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation 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.

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.