Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder

July 13, 2020 updated by: Brainsway

A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)

The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, randomized double blind, sham controlled study to evaluate the safety and efficacy of H-coil deep transcranial magnetic stimulation (dTMS) as a treatment for patients with major depressive disorder who have been previously unsuccessfully treated with antidepressant medications. Studies of repetitive transcranial magnetic stimulation (rTMS), typically using a figure-8 coil, have shown that stimulating superficial brain regions can be beneficial in treating major depression. Differing from traditional figure-8 coil, the H-coil is designed to stimulate deep brain regions related to motivation, reward, and pleasure. Preliminary studies have been conducted and seem to indicate that through stimulating certain brain areas with the H-coil, dTMS may have an antidepressant effect. The study population will consist of patients with major depressive disorder who have failed adequate medication treatment or shown significant intolerance to medications. The study duration is 18 weeks, with a 2 week period of weaning the patient off medication, followed by 4 weeks of 5 daily treatments and 12 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and rating during the drug taper-down and throughout treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
233

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Center for Addiction and Mental Health (CAMH)
  • France
      • Neuilly Sur Marne, France, 93332
        • EPS Ville-Evrard
  • Germany
      • Bonn, Germany
        • Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
      • Munich, Germany
        • Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
  • Israel
      • Beer Yaacov, Israel
        • Beer Yaacov Mental Health Center
      • Hod Hasharon, Israel
        • Shalvata Mental Health Center
      • Jerusalem, Israel
        • Kfar Shaul Mental Health Center
      • Jerusalem, Israel
        • Hadasah Ein-Karem Medical Center
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California (UCLA)
      • Sacramento And Davis, California, United States, 95817
        • UC Davis Center for Mind & Brain
      • Santa Monica, California, United States, 90403
        • Smart Brain and Health
    • Florida
      • Juno Beach, Florida, United States, 33408
        • Advanced Mental Health Care Inc. - Juno Beach
      • Royal Palm Beach, Florida, United States, 33411
        • Advanced Mental Health Care Inc. - Royal Palm Beach
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital - TMS Services
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Greater Nashua Mental Health Center
    • New York
      • New York, New York, United States, 10021
        • Neuropharmacology Services
      • New York, New York, United States, 10032
        • Columbia University / New York State Psychiatric Institute
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center Department of Psychiatry & Behavioral Sciences
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Uni. Of South Carolina (MUSC)
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
      • Dallas, Texas, United States, 75390-8898
        • UT Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients.
  • Men and women 22-68 years of age.
  • Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.
  • Current depressive episode is less than 5 years duration.
  • The patient did not respond to at least one but not more than four antidepressant treatments in the current episode.
  • Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode.
  • Satisfactory safety screening questionnaire for transcranial magnetic stimulation.
  • Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level or medically stabilized.
  • Patients able to tolerate psychotropic medication washout and no psychotropics during the treatment, other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.

Exclusion Criteria:

  • A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD, eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse
  • A history of panic disorder, social anxiety disorder or personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
  • A history of any significant medical disease (i.e., cardiovascular, gastrointestinal, etc.)
  • A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
  • Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.
  • Received ECT within the last 3 months or failed to respond to ECT treatment.

  • Individuals with a significant neurological disorder or insult including:

    • Any condition likely to be associated with increased intracranial pressure
    • Space occupying brain lesion
    • Any history of seizure EXCEPT those therapeutically induced by ECT
    • History of cerebrovascular accident
    • Transient ischemic attack within two years
    • Cerebral aneurysm
    • Dementia
    • Parkinson's disease
    • Huntington's chorea
    • Multiple sclerosis
  • Individuals with hearing loss.
  • Any intracranial implant such as aneurysm clips, shunts, stimulators, cochlear implants, or electrodes, or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  • A cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
  • Use of fluoxetine within 6 weeks of the randomization visit.
  • Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the randomization visit.
  • Present suicidal risk as assessed by the investigator.
  • Implanted neurostimulators.
  • History of abnormal MRI.
  • If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.
  • Clinically significant laboratory abnormality, in the opinion of the Investigator based on CBC and biochemistry.
  • Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
  • Women: if pregnant, planning on becoming pregnant, or currently nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham
Sham treatment
Device: Brainsway H-Coil Deep TMS System (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.
Active Comparator: Active
Active Deep Transcranial Magnetic Stimulation treatment
Device: Brainsway H-Coil 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 H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
HDRS-21
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Response rate
Time Frame: 5 weeks
5 weeks
Remission rates
Time Frame: 5 weeks
5 weeks
Quality of Life
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brainsway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yechiel Levkovitz, M.D, Shalvat Mental Health Center
  • Principal Investigator: Abraham Zangen, Dr., Weizmann Institute of Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP-0001-00
  • IL-MOH-HTA-4860

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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