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

NCT ID: NCT02479906

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-17
• Study Completion Date: 2020-03-31

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.

Detailed Description

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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham Treatment

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.

Group Type: SHAM_COMPARATOR

Sham Treatment

Intervention Type: 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

Deep TMS System

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.

Group Type: EXPERIMENTAL

Deep TMS System

Intervention Type: 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.

Interventions

Deep TMS System

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.

Intervention Type: DEVICE

Sham Treatment

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Isserles, MD

Role: PRINCIPAL_INVESTIGATOR

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

Zafiris J. Daskalakis, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Addiction and Mental Health (CAMH)

Avraham Zangen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Locations

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

Countries

United States; Canada; Israel

References

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.

Reference Type: DERIVED

PMID: 34274108 (View on PubMed)

Other Identifiers

CTP-PTSD-01

Identifier Type: -

Identifier Source: org_study_id