Eligibility Details:
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.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
