Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

Brief Summary

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

The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are:

type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).

Related Clinical Trials

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

Treating Refractory Major Depressive Disorder With Repetitive Transcranial Magnetic Stimulation

NCT00305045

Major Depressive Disorder

COMPLETED NA

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

NCT01409317

Major Depressive Disorder

COMPLETED PHASE2/PHASE3

Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

NCT02213016

Major Depression

UNKNOWN PHASE4

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

NCT02184221

Major Depressive Disorder

COMPLETED NA

rTMS and Cognitive Training in Youth Depression

NCT03708172

Depression

COMPLETED NA

Detailed Description

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

The primary aim of this trial is to compare the effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). Compared to rTMS, dTMS delivers a broader magnetic field, which in turn reduces coil positioning error and maximizes the probability of optimal cortical stimulation. A past RCT comparing both approaches found a greater depression score decrease and response/remission rates for dTMS, but was short of reaching significance for remission rates (primary outcome). Critical components of this RCT were suboptimal, including too few treatment sessions and insufficient statistical power, both of which could have obscured an actual difference between modalities. Proof of a more effective type of TMS over another would translate into increased odds of improvement for TRD patients who live with a chronic and disabling illness.

Conditions

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

Major Depressive Disorder

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, single-center, two-arm, parallel-group superiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Given the study's design, blinding participants and TMS operators will not be possible. Still, staff responsible for participant assessments and data analysis will be blinded to treatment conditions and external to the clinic staff. Patients will be instructed not to reveal their group assignment to the raters. Patients will not be given the specifics of the treatment parameters and will be instructed not to talk to each other during the study period. Both treatments will be presented as effective to them. Lastly, the data management center will strictly control access to the randomization code.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

repetitive Transcranial Magnetic Stimulation

rTMS on a MagPro X100 research grade stimulator (MagVenture) equipped with a B70 fluid-cooled coil. Participant will receive the MDD FDA-approved iTBS protocol (triplet 50 Hz bursts repeated at 5 Hz, 2 s ON and 8 s OFF; 600 pulses per session; total duration of 3 min 9 s, 120% hand motor threshold)

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

Participants will receive either rTMS or dTMS

deep Transcranial Magnetic Stimulation

dTMS on a research Brainsway system equipped with an H7-Coil. Participants will receive the MDD FDA-cleared 18 Hz stimulation protocol (2 sec ON, 20 sec OFF, 55 trains; 1980 pulses per session; 20 min 10 s duration; 120% hand motor threshold)

Group Type EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type DEVICE

Participants will receive either rTMS or dTMS

Interventions

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

transcranial magnetic stimulation

Participants will receive either rTMS or dTMS

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

deep transcranial magnetic stimulation

Eligibility Criteria

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

Inclusion Criteria

* Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode
* HRSD-17 score of at least 18
* No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration
* On a stable antidepressant regimen for the past four weeks before screening
* Patients with a chronic depressive episode \>2 years and who have previously received ECT or ketamine will be eligible to participate

Exclusion Criteria

* Having previously received TMS;
* Substance use disorder within the last three months
* Diagnosis of bipolar or psychosis spectrum disorder
* Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD
* Concomitant major unstable medical or neurological illness
* Intracranial implant, cardiac pacemaker or implanted medication pump
* Significant laboratory abnormality;
* Active suicidal intent
* Pregnancy
* If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change
* Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No