Clinical trial NCT02479906: A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Post-Traumatic Stress Disorder
PTSD
dTMS
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 203
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CAPS-5 Score
timeFrame: 5 weeks from baseline
Secondary outcomes:
measure: Response Rate
timeFrame: 5 weeks from baseline
Other outcomes:
measure: Adverse events
timeFrame: 5 and 9 weeks
measure: Changes in Cognitive Scales
timeFrame: 5 and 9 weeks
Locations:
city: Los Angeles
country: United States
facility: CalNeuro Research Group
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: University of California - San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Kadima Neuropsychiatry
state: California
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Juno Beach
country: United States
facility: Advanced Mental Health Care Inc. - Juno Beach
state: Florida
city: Palm Beach
country: United States
facility: Advanced Mental Health Care Inc.-Palm Beach
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Royal Palm Beach
state: Florida
city: Evanston
country: United States
facility: Yellowbrick Foundation
state: Illinois
city: New York
country: United States
facility: TMS Hope Center of Long Island
state: New York
city: Raleigh
country: United States
facility: Carolina Partners in Mental Healthcare PLLC
state: North Carolina
city: Charleston
country: United States
facility: Medical University Of South Carolina (MUSC)
state: South Carolina
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health (CAMH)
state: Ontario
city: Be'er Ya'aqov
country: Israel
facility: Be'er Yaacov Mental Health Center
city: Tel Hashomer
country: Israel
facility: Tel Hashomer Hospital
Study officials:
affiliation: Hadassah Ein Karem Medical Center and Center for Addiction and Mental Health (CAMH)
name: Moshe Isserles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Addiction and Mental Health (CAMH)
name: Zafiris J. Daskalakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Avraham Zangen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.