Home
Clinical Trials
Combining H1-Coil Deep Transc...

Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-26

Study Completion Date

2021-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A naturalistic study design, in which dTMS patients will be randomized to get a free add-on CBT treatment. The dTMS procedure will include treatment as usual, and participants will use the app from post randomization (Pre-treatment is defined as measures from the first three days of treatment) to the end of dTMS treatment (Post-treatment which is defined as measures from after twenty TMS sessions over a minimum of four weeks), and for an additional three months of FU (FU).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)

NCT01361815

Major Depressive Disorder, Recurrent, Unspecified Major Depressive Disorder, Single Episode, Unspecified

COMPLETED NA

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

NCT00927173

Major Depressive Disorder

COMPLETED NA

Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

NCT01566591

Bipolar Depression

UNKNOWN NA

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

NCT00445237

Major Depression

COMPLETED PHASE1

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

NCT03012724

Major Depressive Disorder (MDD)

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be recruited from those attending dTMS clinics around the world (i.e.,naturalistic study design), and consenting individuals (in person consent done in the clinic on paper) will be given a random user code. This code will be specific for their version of the app, and the only link between their signature and the code will remain at the site for auditing purposes. Participants will undergo treatment as usual of dTMS and will use GGDE twice a day. Participants will be asked to complete demographic and clinical questionnaires via the GGDE app, and relevant clinical questionnaires will be re-administered following treatment and during FU. The initial and all following dTMS sessions will involve patients going through the stimulation procedure (The operator will record stimulation variables such as individual patient's intensity of stimulation and coil location into GGDE) followed by 5 min of GGDE use. The patient will indicate which statements (in that session) were most relevant and challenging to them, which will be followed by a pre-prepared psycho-education paragraph about the specific maladaptive belief addressed by the app that day. The patient will then be prompted to use the app one more time at home during the same day. Patient will continue similar use during FU, with two GGDE usage each day. The naturalistic design will allow the accumulation of large quantities of data in a short period of time, aiming to optimize GGDE using machine learning. Importantly, GGDE will allow the random allocation of users to different GGDE modules of the app (i.e., similar app versions with changes in specific parameters related to different depressive traits). One out of the ten modules used in this trial will include neutral (placebo) stimuli requiring the user to respond to plus/minus signs rather than MDD relevant statements.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Data Collection for Facilitation of Machine Learning Algorithm for Personalized Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT-based, mobile-delivered, intervention platform

App of this platform have been shown to be associated with reduced psychopathology symptoms,including depressive symptoms, following treatment (i.e., relapse prevention). GGDE, which was specifically designed to address MDD related maladaptive beliefs and symptoms,includes different CBT-based intervention modules (nine active and one sham), as well as means for data collection and response monitoring. The active treatment modules will differ in the proportion of adaptive vs. maladaptive statements and the emphasis on particular content (e.g loneliness vs. hopelessness).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult outpatients accepted to treatment as usual dTMS with a Primary DSM-V diagnosis of Major Depression, single or recurrent episode
* Capable and willing to provide informed consent
* In a possession of a Smartphone capable of running the GGDE app.
* Able to adhere to the treatment schedule.

Exclusion Criteria

Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).

\-

Minimum Eligible Age

22 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Reach out to these primary contacts for questions about participation or study logistics.

Aron Tendler, MD

Role: CONTACT

[email protected]

(561) 333-8884

Amit Ezra, MA

Role: CONTACT

[email protected]

+972503103134 ext. +972503103134

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

David Feifel, MD

Role: primary

[email protected]

858-412-4130

Elyssa Sisko

Role: primary

[email protected]

561-267-8876

Elyssa Sisko

Role: primary

[email protected]

703-356-1568

Kirsten Burke

Role: backup

703-356-1568

William Sauvé, MD

Role: primary

[email protected]

757-320-0224

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neural Predictors and Longitudinal Neural Correlates of Deep Transcranial Magnetic Stimulation for Treating Major Depression

NCT01409317 COMPLETED PHASE2/PHASE3

Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual

NCT02260765 WITHDRAWN NA

Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

NCT02213016 UNKNOWN PHASE4

Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder

NCT00104611 COMPLETED PHASE3

Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

NCT03665831 RECRUITING NA

Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly

NCT01521052 UNKNOWN PHASE2

Deep rTMS for Treatment-Resistant Late-life Depression

NCT01860157 COMPLETED NA

Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder

NCT02184221 COMPLETED NA

iCBT With TMS in Patients With MDD

NCT05988619 COMPLETED NA

Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)

NCT02559466 COMPLETED NA

Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

NCT04956016 RECRUITING NA

Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD

NCT02458521 UNKNOWN NA

Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)

NCT03718013 COMPLETED NA

Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode

NCT00807105 COMPLETED PHASE2

Targeting Specific Brain Networks to Treat Specific Symptoms in Depression

NCT05523817 RECRUITING NA

A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)

NCT02479906 TERMINATED NA

In-patient SCC TMS

NCT05645575 RECRUITING NA

Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment

NCT01464515 UNKNOWN PHASE1

Magnetic Brain Stimulation for the Treatment of Adult Depression

NCT00149838 COMPLETED PHASE2/PHASE3

Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

NCT01409304 COMPLETED PHASE2/PHASE3

Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

NCT01415154 COMPLETED NA

Evaluation of the H1-Coil TMS- Double Blind Placebo Controlled Study in Adolescent Patients Suffering From Major Depression

NCT03541707 UNKNOWN NA

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

NCT06524505 RECRUITING NA

Deep TMS of Neural Circuits Associated With Stimulant Use Disorder

NCT06578429 RECRUITING NA

Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

NCT06728280 RECRUITING NA

Combining H1-Coil Deep Transcranial Magnetic Stimulation (dTMS) and App-guided CBT in Subjects With Major Depression Disorder (MDD)

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)

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

Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

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

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

Detailed Description

Conditions

Study Design

Interventions

CBT-based, mobile-delivered, intervention platform

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Brainsway

Responsible Party

Locations

Kadima Neuropsychiatry

Advanced Mental Health Care Inc. - Juno Beach

Advanced Mental Health Care Inc. - Palm Beach

Advanced Mental Health Care Inc. - Royal Palm Beach

Greenbrook - Annapolis

Greenbrook - Columbia

Greenbrook - Frederick

Greenbrook - Glen Burnie

Greenbrook - Greenbelt

Greenbrook - Kensington

Greenbrook - Olney

Greenbrook - Rockville

Greenbrook - O'Fallon

Greenbrook - Tesson Ferry

Greenbrook - Creve Coeur

Greenbrook - Chapel Hill

Greenbrook - Greensboro

Greenbrook - Matthews

Greenbrook - Raleigh

Greenbrook - Glen Allen

Greenbrook TMS NeuroHealth Centers

Greenbook - Newport News

Countries

Central Contacts

Aron Tendler, MD

Amit Ezra, MA

Facility Contacts

David Feifel, MD

Elyssa Sisko

Elyssa Sisko

Elyssa Sisko

Hanita Chhabra, MD

Misty Borst, MD

Joshua Sussal, MD

Hanita Chhabra, MD

Joshua Sussal, MD

Geoffrey Grammer, MD

Joshua Sussal, MD

Geoffrey Grammer, MD

Howard Ilivicky, MD

Steven Harvey, MD

Robert Rifkin, MD

Andrea Hernandez, MD

Keshavpal Reddy, MD

Darlene Ifill-Taylor, MD

Kellie Tolin, MD

William Sauvé, MD

Jessica Oleksik

Kirsten Burke

William Sauvé, MD

Other Identifiers

101

More Related Trials