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An Evaluation of the Safety and Efficacy of the dTMS Treatment for OCD

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229903
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Brainsway

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE September 3, 2014
Last Update Posted Date July 15, 2020
Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Yale Brown Obsessive Compulsive Scale (YBOCS) score [ Time Frame: 6 Weeks ]
The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the 6 week (post-randomization) visit, between the two treatments groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Yale Brown Obsessive Compulsive Scale (YBOCS), Sheehan Disability Scale (SDS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: 6 Weeks and 10 weeks ]
The secondary effectiveness objectives of the study are: i. Change from baseline to 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) (and other assessment scale) scores, between treatment groups. ii. Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups; iii.Partial Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score, between treatment groups; iv. Change from baseline to 10 weeks in above scales. v. Remission rates at 6 weeks between treatment groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 28, 2014)
Number of adverse events, changes in vitals signs, physical and neurological results, changes in suicide scale and changes in cognitive scales [ Time Frame: 10 Weeks ]
Safety of the DTMS treatment as defined by maintained subject baseline, pre-treatment, physical and neurological examinations and lack of significant increase in suicide ideation measured by:
  • Vital signs
  • Physical and neurological examination
  • Scale for Suicide Ideation
  • Cognitive evaluation using the Mini-Mental State Exam (MMSE), Buschke Selective Reminding Test (BSRT) and Autobiographical Memory Interview - Short Form (AMI-S) scales
  • Any other adverse events (AEs).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Safety and Efficacy of the dTMS Treatment for OCD
Official Title  ICMJE A Prospective Double Blind Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (dTMS) in Obsessive-Compulsive Subjects
Brief Summary The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS) treatment in subjects with OCD. The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS treatment to sham treatment.
Detailed Description The OCD study will compare one group of OCD subjects receiving DTMS treatment (HAC-coil) to a second group of OCD subjects receiving sham treatment (sham coil). The treatment group will receive 5 weeks of daily DTMS treatments followed by 4 treatments in week 6, for a total of 29 treatment sessions. The control group will receive the same treatments with a sham coil. Subjects may continue to take SSRI medications (if prescribed) and any other antidepressant medications will be tapered down prior to the first treatment. SSRI medications approved for OCD include Fluoxetine (Prozac, Sarafem, Symbyax), Fluvoxamine (Luvox, Luvox CR), Paroxetine (Paxil, Paxil CR, Pexeva) and Sertraline (Zoloft). Efficacy will be assessed using the Yale-Brown Obsessive Compulsive Scale score (YBOCS), as well as other efficacy scales. Safety will be assessed by monitoring of adverse events, vital signs, physical and neurological examination and using certain safety questionnaires.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive Compulsive Disorder
Intervention  ICMJE
  • Device: Active DTMS Treatment
    H-coil Deep TMS 29 TMS treatments over 6 weeks.
  • Device: Sham Treatment
    29 treatments over 6 weeks.
    Other Name: Deep TMS Sham treatment
Study Arms  ICMJE
  • Active Comparator: Active DTMS Treatment
    Active DTMS Treatment constitutes the Deep Transcranial Magnetci Stimulation (DTMS) which is a new form of TMS which allows direct stimulation of deeper neruonal pathways than the standard TMS. The DTMS coil is designed to allow deeper brain stimulation without significant increase of electric fields included in superficial cortical regions.
    Intervention: Device: Active DTMS Treatment
  • Sham Comparator: Sham Treatment
    The Sham Treatment consists of an electrical field which 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
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
98
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- • Outpatients

  • Men and women 22-68 years of age.
  • Subjects diagnosed as suffering from OCD according to the DSM-IV-TR.
  • Subjects with at least moderate OCD, rating a YBOCS score of >20.
  • Subjects are maintained on SSRI medication at at least a therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial and/or subjects are maintained on psychotherapeutic behavioral intervention therapy (subjects undergoing CBT treatment must be in the maintenance stage (i.e., not during the assessment or skills acquisition or training stages).
  • Subjects with negative responses on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
  • According to the treating physician the subject is compliant with taking medication, if applicable.
  • Subject is capable and willing to provide informed consent.
  • Subject is able to adhere to the treatment schedule.

Exclusion Criteria:

- • Subjects diagnosed according to the SCID I as suffering from any other Axis I diagnosis as the primary diagnosis.

  • Subjects diagnosed according to the SCID II as suffering from severe Personality Disorder (excluding Obsessive Compulsive Personality Disorder) or hospitalized due to exacerbation related to borderline personality disorder.
  • Present suicidal risk as assessed by the investigator using the Scale for Suicide Ideation (SSI), brief mental status exam and psychiatric interview or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the past year.
  • Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first degree relatives.
  • Subject has an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
  • Subject has a history of head injury necessitating cranial surgery or prolonged coma.
  • Subject has a history of any metal in the head including the eyes and ears (outside the mouth).
  • Subject has known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
  • Subject has a history of significant hearing loss.
  • Subjects with significant neurological disorder or insult including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure
  • Subject has a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
  • Inadequate communication with the patient.
  • Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
  • Subjects who suffer from an unstable physical, systemic and metabolic disorder such as unstabilized blood pressure or acute, unstable cardiac disease.
  • Subject is currently on any antidepressant medication other than SSRIs.
  • Subject is currently on Clomipramine
  • Subject has had previous treatment with TMS
  • Women who are breast-feeding
  • Women who are pregnant or with suspected pregnancy
  • Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Israel,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT02229903
Other Study ID Numbers  ICMJE CTP-OCD-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: Joseph Zohar, Prof Tel Hashomer Hospital
Principal Investigator: Abraham Zangen, Prof Soroka University Medical Center
PRS Account Brainsway
Verification Date February 2017

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