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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brainsway
ClinicalTrials.gov Identifier:
NCT00927173
First received: June 23, 2009
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Device: Brainsway H-Coil Deep TMS System
Device: Brainsway H-Coil Deep TMS System (Sham treatment)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Brainsway:

Primary Outcome Measures:
  • HDRS-21 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Remission rates [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   22 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927173

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

No publications provided

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT00927173     History of Changes
Other Study ID Numbers: CTP-0001-00, IL-MOH-HTA-4860
Study First Received: June 23, 2009
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brainsway:
TMS
Transcranial Magnetic Stimulation
MDD
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Disease
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Pathologic Processes
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014