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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Post-Traumatic Stress Disorder

In brief

The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.

Key facts

Study ID

NCT02479906

Run by

Brainsway

People needed

203

Starts

2016-11-17

Expected to finish

2020-03-31

Last updated by the study team

2020-05-14

Who can join

Age: 22 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify 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.

Where it is running

• CalNeuro Research Group — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California - San Diego Medical Center — San Diego, California, United States
• Kadima Neuropsychiatry — San Diego, California, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, United States
• Advanced Mental Health Care Inc.-Palm Beach — Palm Beach, Florida, United States
• Advanced Mental Health Care Inc. - Royal Palm Beach — Royal Palm Beach, Florida, United States
• Yellowbrick Foundation — Evanston, Illinois, United States
• TMS Hope Center of Long Island — New York, New York, United States
• Carolina Partners in Mental Healthcare PLLC — Raleigh, North Carolina, United States
• Medical University Of South Carolina (MUSC) — Charleston, South Carolina, United States
• Center for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada
• Be'er Yaacov Mental Health Center — Be’er Ya‘aqov, Israel
• Tel Hashomer Hospital — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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