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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02479906
• Other study ID #: CTP-PTSD-01
• Status: Terminated
• Phase: N/A
• Start date: November 17, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 203
• Est. completion date: March 31, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• 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.
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Measured by vital signs, physical & neurological examinations, lack of significant increase in suicide ideation, & other adverse event reporting.	5 and 9 weeks
Other	Changes in Cognitive Scales	Changes in MMSE and BSRT Scales	5 and 9 weeks
Primary	CAPS-5 Score	CAPS-5 Score measured by change from baseline.	5 weeks from baseline
Secondary	Response Rate	Response rate at the 5 week follow-up visit.	5 weeks from baseline