NCT02229903

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 15, 2020

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

August 7, 2014

Last Update Submit

July 13, 2020

Conditions

Obsessive Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale (YBOCS) score

    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.

    6 Weeks

Secondary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale (YBOCS), Sheehan Disability Scale (SDS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I)

    6 Weeks and 10 weeks

Other Outcomes (1)

  • Number of adverse events, changes in vitals signs, physical and neurological results, changes in suicide scale and changes in cognitive scales

    10 Weeks

Study Arms (2)

Active DTMS Treatment

ACTIVE COMPARATOR

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.

Device: Active DTMS Treatment

Sham Treatment

SHAM COMPARATOR

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.

Device: Sham Treatment

Interventions

Active DTMS TreatmentDEVICE

H-coil Deep TMS 29 TMS treatments over 6 weeks.

Active DTMS Treatment
Sham TreatmentDEVICE

29 treatments over 6 weeks.

Also known as: Deep TMS Sham treatment
Sham Treatment

Eligibility Criteria

Age22 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- • 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.

You may not qualify if:

  • \- • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of California (UCLA)

Los Angeles, California, 90095, United States

Location

University of California

San Diego, California, 92093, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32603, United States

Location

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, 33408, United States

Location

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, 33411, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Neuropharmacology Services

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

TMS Hope Center of Long Island

New York, New York, 11777, United States

Location

Lindner Center of HOPE, University of Cincinnati College of Medicine

Mason, Ohio, 45040, United States

Location

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

Tel Hashomer Hospital

Tel Litwinsky, 52621, Israel

Location

Related Publications (3)

  • Harmelech T, Tendler A, Roth Y, Zangen A. Do comorbid OCD-MDD patients need two separate dTMS protocols? Brain Stimul. 2020 Jul-Aug;13(4):1000-1001. doi: 10.1016/j.brs.2020.03.014. Epub 2020 Mar 31. No abstract available.

    PMID: 32380442DERIVED

  • Crowell AL, Riva-Posse P, Holtzheimer PE, Garlow SJ, Kelley ME, Gross RE, Denison L, Quinn S, Mayberg HS. Long-Term Outcomes of Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression. Am J Psychiatry. 2019 Nov 1;176(11):949-956. doi: 10.1176/appi.ajp.2019.18121427. Epub 2019 Oct 4.

    PMID: 31581800DERIVED

  • Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.

    PMID: 31109199DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Joseph Zohar, Prof

    Tel Hashomer Hospital

    PRINCIPAL INVESTIGATOR

  • Abraham Zangen, Prof

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

September 3, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 15, 2020

Record last verified: 2017-02

Locations

IL(1)US(10)CA(1)