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

NCT ID: NCT00927173

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Major Depressive Disorder

Study Design

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

Study Groups

Sham

Sham treatment

Group Type: SHAM_COMPARATOR

Brainsway H-Coil Deep TMS System (Sham treatment)

Intervention Type: DEVICE

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

Active Deep Transcranial Magnetic Stimulation treatment

Group Type: ACTIVE_COMPARATOR

Brainsway H-Coil Deep TMS System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• 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

Yechiel Levkovitz, M.D

Role: PRINCIPAL_INVESTIGATOR

Shalvat Mental Health Center

Abraham Zangen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Weizmann Institute of Science

Locations

University of California (UCLA)

Los Angeles, California, United States

UC Davis Center for Mind & Brain

Sacramento and Davis, California, United States

Smart Brain and Health

Santa Monica, California, 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

Johns Hopkins University

Baltimore, Maryland, United States

McLean Hospital - TMS Services

Belmont, Massachusetts, United States

Greater Nashua Mental Health Center

Nashua, New Hampshire, United States

Neuropharmacology Services

New York, New York, United States

Columbia University / New York State Psychiatric Institute

New York, New York, United States

Duke Medical Center Department of Psychiatry & Behavioral Sciences

Durham, North Carolina, United States

Medical Uni. Of South Carolina (MUSC)

Charleston, South Carolina, United States

Senior Adults Specialty Research

Austin, Texas, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

EPS Ville-Evrard

Neuilly-sur-Marne, , France

Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, , Germany

Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität

Munich, , Germany

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

Countries

United States; Canada; France; Germany; Israel

Other Identifiers

IL-MOH-HTA-4860

Identifier Type: -

Identifier Source: secondary_id

CTP-0001-00

Identifier Type: -

Identifier Source: org_study_id