Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02479906
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479906
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Brainsway

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 24, 2015
Last Update Posted Date January 29, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
CAPS-5 Score [ Time Frame: 5 weeks from baseline ]
CAPS-5 Score measured by change from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02479906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Response Rate [ Time Frame: 5 weeks from baseline ]
Response rate at the 5 week follow-up visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2015)
  • Adverse events [ Time Frame: 5 and 9 weeks ]
    Measured by vital signs, physical & neurological examinations, lack of significant increase in suicide ideation, & other adverse event reporting.
  • Changes in Cognitive Scales [ Time Frame: 5 and 9 weeks ]
    Changes in MMSE and BSRT Scales
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Sham Comparator: 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.
    Intervention: Device: Sham Treatment
  • Experimental: 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.
    Intervention: Device: Deep TMS System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
176
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2015)
166
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amit Ezra 972-503103134 amite@Brainsway.com
Contact: Amit Ginou 972-526051372 amit@Brainsway.com
Listed Location Countries  ICMJE Canada,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02479906
Other Study ID Numbers  ICMJE CTP-PTSD-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brainsway
Study Sponsor  ICMJE Brainsway
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account Brainsway
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP