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

NCT ID: NCT02229903

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active DTMS Treatment

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham Treatment

Intervention Type: DEVICE

29 treatments over 6 weeks.

Interventions

Active DTMS Treatment

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

Intervention Type: DEVICE

Sham Treatment

29 treatments over 6 weeks.

Intervention Type: DEVICE

Other Intervention Names

Deep TMS Sham treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Zohar, Prof

Role: PRINCIPAL_INVESTIGATOR

Tel Hashomer Hospital

Abraham Zangen, Prof

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

University of California (UCLA)

Los Angeles, California, United States

University of California

San Diego, California, United States

University of Florida College of Medicine

Gainesville, Florida, United States

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, United States

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, United States

University of Chicago

Chicago, Illinois, United States

Neuropharmacology Services

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

TMS Hope Center of Long Island

New York, New York, United States

Lindner Center of HOPE, University of Cincinnati College of Medicine

Mason, Ohio, United States

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Tel Hashomer Hospital

Tel Litwinsky, , Israel

Countries

United States; Canada; Israel

References

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.

Reference Type: DERIVED

PMID: 32380442 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31581800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31109199 (View on PubMed)

Other Identifiers

CTP-OCD-01

Identifier Type: -

Identifier Source: org_study_id