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



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:22 - 68
Updated:1/31/2019
Start Date:June 2015
End Date:September 2019
Contact:Amit Ezra
Email:amite@Brainsway.com
Phone:972-503103134

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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)

The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS
(DTMS) for the treatment of 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.
We found this trial at
13
sites
Palm Beach, Florida 33480
Principal Investigator: Aron Tendler, MD
Phone: 561-333-8884
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Charleston, South Carolina 29425
Principal Investigator: Mark George, MD
Phone: 843-577-5011
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Charleston, SC
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Evanston, Illinois 60201
Principal Investigator: Jesse Viner, MD
Phone: 847-563-0562
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Evanston, IL
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3450 Hull Road
Gainesville, Florida 32610
Principal Investigator: Herb Ward, MD
Phone: 352-281-0032
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Gainesville, FL
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Juno Beach, Florida 33408
Principal Investigator: Aron Tendler, MD
Phone: 561-333-8884
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Juno Beach, FL
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10850 Wilshire Boulevard
Los Angeles, California 90024
Principal Investigator: Alexander Bystritsky
Phone: 310-208-7144
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Los Angeles, CA
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1739 North Ocean Avenue
New York, New York 11777
Principal Investigator: Kyle Lapidus
Phone: 631-509-6111
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New York, NY
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Palo Alto, California 94304
Principal Investigator: Mahendra T Bhati
Phone: 509-845-3538
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Palo Alto, CA
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Raleigh, North Carolina 27609
Principal Investigator: Sandeep Vaishnavi
Phone: 919-792-3940
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Raleigh, NC
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Royal Palm Beach, Florida 33411
Principal Investigator: Aron Tendler, MD
Phone: 561-333-8884
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Royal Palm Beach, FL
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San Diego, California 92103
Principal Investigator: David Feifel, MD
Phone: 619-543-5978
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San Diego, CA
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3252 Holiday Court
San Diego, California 92037
Principal Investigator: David Feifel, MD
Phone: 858-412-4130
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San Diego, CA
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Toronto, Ontario
Principal Investigator: Zafiris J. Daskalakis, MD
Phone: 416-535-8501
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Toronto,
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