Recruiting

H7-Coil vs. H1-CoilEfficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)

Sponsor:

Brainsway

Code:

NCT03012724

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 22 - 68

Healthy Volunteers: Not accepted

Interventions

H7-Coil

H1-Coil

Study Details

Brief summary:

The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medications.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT03012724

Start date

Mar 30, 2017

Status verified date

Jan, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 68

Healthy Volunteers: Not accepted

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 or 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
Capable and willing to provide informed consent and able to adhere to the treatment schedule
Patient is stable on medication for 2 month and is not expected to change medication during all study period

Exclusion Criteria:

Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):

Depression secondary to a general medical condition, or substance-induced
History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features, Bipolar disorder, Eating disorder, Obsessive compulsive disorder
Post-traumatic stress disorder (current or within the past year)
Current generalized anxiety disorder, panic disorder or social anxiety disorder
Presence of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic)
Individuals with a significant neurological disorder or insult including, but not limited to:

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
Mini Mental State Exam score of less than or equal to 24
Parkinson's disease
Huntington's chorea
Multiple sclerosis
Increased risk of seizure for any reason
Individuals with hearing loss
ECT treatment within 3 months prior to the screening visit
History of treatment with Vagus Nerve Stimulation (VNS)
History of treatment with Deep Brain Stimulation (DBS)
Use of any investigational drug within 4 weeks of the randomization visit
Use of any prohibited study medication(s)
Present suicidal risk as assessed by the investigator or significant suicide risk
Any self-inflicted harm in the past 3 months not in the context of suicidal ideation
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
Intracranial implant (e.g., 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
Implanted neurostimulators
History of abnormal MRI
Known or suspected pregnancy
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 Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: H1-Coil

Device: Brainsway H1-Coil Deep TMS System. An FDA cleared deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the lateral prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.

experimental: H7-Coil

Device: Brainsway H7-Coil Deep TMS System. A deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the medial prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.

Interventions

H7-Coil

Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil

H1-Coil

Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil

Primary outcome measure

HDRS-21 Score Change From Baseline [ Time Frame: Week 6 post randomization ]

Central Contacts and Locations

Central contacts

Amit Ezra

+972-503103134 amite@brainsway.com

Locations

Kadima Neuropsychiatry

Recruiting

La Jolla, California, United States, 92037

Contacts

Cheryl Jacobson

858-412-4130 clinicaltrials@kadimanp.com

Principal Investigator:

David Feifel, MD

CalNeuro Research Group

Recruiting

Los Angeles, California, United States, 90024

Contacts

Christina Fosteson

310-208-7144 cfosteson@calneuroresearch.com

Principal Investigator:

Alexander Bystritsky

Advanced Mental Health Care Inc. - Juno Beach

Recruiting

Juno Beach, Florida, United States, 33408

Contacts

Elyssa Sisko

561-267-8876 elyssasisko@gmail.com

Principal Investigator:

Aron Tendler, MD

Advanced Mental Health Care Inc. - Palm Beach

Recruiting

Palm Beach, Florida, United States, 33480

Contacts

Elyssa Sisko

561-333-8884

561-386-1600

Principal Investigator:

Aron Tendler

Advanced Mental Health Care Inc. - Royal Palm Beach

Recruiting

Royal Palm Beach, Florida, United States, 33411

Contacts

Elyssa Sisko

561-267-8876 elyssasisko@gmail.com

Principal Investigator:

Aron Tendler, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Morgan Dancy, BsC

maddoxm@musc.edu

Principal Investigator:

Mark George, MD

Greenbrook TMS NeuroHealth Centers

Recruiting

McLean, Virginia, United States, 22102

Contacts

Jessica Oleksik

703-356-1568 joleksik@greenbrooktms.com

Kirsten Burke

703-356-1568

Principal Investigator:

Geoffrey Grammer, MD

Center for Addiction & Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Shobha Mehta

416-5358501 Shobha.Mehta@camh.ca

Principal Investigator:

Daniel Blumberger, MD

More Information

Sponsor

Brainsway

Last update posted

Jul 15, 2020

Last verified

Jan, 2020

Keywords

TMS
Deep Transcranial Magnetic Stimulation
MDD
Major Depressive Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brainsway on 2020-07-15.