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

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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

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Device: Deep TMS System Device: Sham Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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.




Primary Outcome Measures :
  1. CAPS-5 Score [ Time Frame: 5 weeks from baseline ]
    CAPS-5 Score measured by change from baseline.


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 5 weeks from baseline ]
    Response rate at the 5 week follow-up visit.


Other Outcome Measures:
  1. 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.

  2. Changes in Cognitive Scales [ Time Frame: 5 and 9 weeks ]
    Changes in MMSE and BSRT Scales



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479906


Contacts
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Contact: Amit Ezra 972-503103134 amite@Brainsway.com
Contact: Amit Ginou 972-526051372 amit@Brainsway.com

Locations
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United States, California
CalNeuro Research Group Recruiting
Los Angeles, California, United States, 90024
Contact: Christina Fosteson    310-208-7144    cfosteson@calneuroresearch.com   
Principal Investigator: Alexander Bystritsky         
Stanford University Recruiting
Palo Alto, California, United States, CA 94304-1212
Contact: Nismeta Kabilovic    509-845-3538    nismeta@stanford.edu   
Principal Investigator: Mahendra T Bhati         
University of California - San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Karin Kriger       kkriger@ucsd.edu   
Principal Investigator: David Feifel, MD         
Kadima Neuropsychiatry Recruiting
San Diego, California, United States
Contact: David Feifel, MD    858-412-4130    dfeifel@kadimanp.com   
Principal Investigator: David Feifel, MD         
United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32603
Contact: Dana Mason    352-281-0032    dmason@ufl.edu   
Principal Investigator: Herb Ward, MD         
Advanced Mental Health Care Inc. - Juno Beach Recruiting
Juno Beach, Florida, United States, 33408
Contact: Elyssa Sisko    561-333-8884    elyssasisko@gmail.com   
Principal Investigator: Aron Tendler, MD         
Advanced Mental Health Care Inc.-Palm Beach Recruiting
Palm Beach, Florida, United States, 33411
Contact: Elyssa Sisko    561-333-8884    elyssasisko@gmail.com   
Contact: Aron Tendler, MD    561-3338884    aron.tendler@gmail.com   
Principal Investigator: Aron Tendler, MD         
Advanced Mental Health Care Inc. - Royal Palm Beach Recruiting
Royal Palm Beach, Florida, United States, 33411
Contact: Elyssa Sisko    561-333-8884    elyssasisko@gmail.com   
Principal Investigator: Aron Tendler, MD         
United States, Illinois
Yellowbrick Foundation Recruiting
Evanston, Illinois, United States, 60201
Contact: Laura Viner, PhD    847-563-0562    LViner@yellowbrickprogram.com   
Principal Investigator: Jesse Viner, MD         
United States, New York
TMS Hope Center of Long Island Recruiting
New York, New York, United States, 11777
Contact: Kyle Lapidus    631-509-6111    kylelapidus@gmail.com   
Principal Investigator: Kyle Lapidus         
United States, North Carolina
Carolina Partners in Mental Healthcare PLLC Recruiting
Raleigh, North Carolina, United States
Contact: Stephanie Garner    919-792-3940    cpmhstephanie@gmail.com   
Principal Investigator: Sandeep Vaishnavi         
United States, South Carolina
Medical University Of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Mathew Schmidt    843-577-5011 ext 5209    matthew.schmidt@va.gov   
Principal Investigator: Mark George, MD         
Canada, Ontario
Center for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada
Contact: Mawahib Semeralul    416-535-8501 ext 30210    Mawahib.Semeralul@camh.ca   
Principal Investigator: Zafiris J. Daskalakis, MD         
Israel
Be'er Yaacov Mental Health Center Recruiting
Be'er Ya'aqov, Israel, 70350
Contact: Dana Niv    972-8-9258474    dana.niv@moh.health.gov.il   
Principal Investigator: Yehiel Levkovitz         
Tel Hashomer Hospital Recruiting
Tel Hashomer, Israel, 52621
Contact: Mor Abraham    972-546631236    abrahammor@gmail.com   
Principal Investigator: Joseph Zohar, Prof.         
Sponsors and Collaborators
Brainsway
Investigators
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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

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Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT02479906     History of Changes
Other Study ID Numbers: CTP-PTSD-01
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Keywords provided by Brainsway:
Post-Traumatic Stress Disorder
PTSD
dTMS

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders