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

NCT02479906 | Terminated DMC

• 1 other identifier: CTP-PTSD-01
• Study Type: interventional
• Target: 203
• Locations: 3 countries
• Sites: 15

Brief Summary

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

Conditions

Post-Traumatic Stress Disorder

Keywords

Post-Traumatic Stress Disorder; PTSD; dTMS

Outcome Measures

Primary Outcomes (1)

• CAPS-5 Score

  CAPS-5 Score measured by change from baseline.

  5 weeks from baseline

Secondary Outcomes (1)

• Response Rate

  5 weeks from baseline

Other Outcomes (2)

• Adverse events

  5 and 9 weeks

• Changes in Cognitive Scales

  5 and 9 weeks

Study Arms (2)

Sham Treatment

SHAM COMPARATOR

In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.

Device: Sham Treatment

Deep TMS System

EXPERIMENTAL

Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The HAC Coil is designed to stimulate neuronal pathways in the medial prefrontal cortex or motor cortex, including the anterior cingulated cortex.

Device: Deep TMS System

Interventions

Deep TMS System DEVICE

Deep TMS treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions.

Deep TMS System

Sham Treatment DEVICE

Sham treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions

Sham Treatment

Eligibility Criteria

• Age: 22 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brainsway: lead

Study Sites (15)

CalNeuro Research Group

Los Angeles, California, 90024, United States

Location

Stanford University

Palo Alto, California, CA 94304-1212, United States

Location

University of California - San Diego Medical Center

San Diego, California, 92103, United States

Location

Kadima Neuropsychiatry

San Diego, California, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32603, United States

Location

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, 33408, United States

Location

Advanced Mental Health Care Inc.-Palm Beach

Palm Beach, Florida, 33411, United States

Location

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, 33411, United States

Location

Yellowbrick Foundation

Evanston, Illinois, 60201, United States

Location

TMS Hope Center of Long Island

New York, New York, 11777, United States

Location

Carolina Partners in Mental Healthcare PLLC

Raleigh, North Carolina, United States

Location

Medical University Of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

Be'er Yaacov Mental Health Center

Be’er Ya‘aqov, 70350, Israel

Location

Tel Hashomer Hospital

Tel Litwinsky, 52621, Israel

Location

Related Publications (1)

• Isserles M, Tendler A, Roth Y, Bystritsky A, Blumberger DM, Ward H, Feifel D, Viner L, Duffy W, Zohar J, Keller CJ, Bhati MT, Etkin A, George MS, Filipcic I, Lapidus K, Casuto L, Vaishnavi S, Stein A, Deutsch L, Deutsch F, Morales O, Daskalakis ZJ, Zangen A, Ressler KJ. Deep Transcranial Magnetic Stimulation Combined With Brief Exposure for Posttraumatic Stress Disorder: A Prospective Multisite Randomized Trial. Biol Psychiatry. 2021 Nov 15;90(10):721-728. doi: 10.1016/j.biopsych.2021.04.019. Epub 2021 May 4.

  PMID: 34274108 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Moshe Isserles, MD

  Hadassah Ein Karem Medical Center and Center for Addiction and Mental Health (CAMH)

  PRINCIPAL INVESTIGATOR

• Zafiris J. Daskalakis, MD

  Center for Addiction and Mental Health (CAMH)

  PRINCIPAL INVESTIGATOR

• Avraham Zangen, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 24, 2015
• Study Start: November 17, 2016
• Primary Completion: February 6, 2020
• Study Completion: March 31, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05

Locations

CA (1); IL (2); US (12)