Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

NCT05902312 | Active Not Recruiting DMC

• 1 other identifier: 2023-11389
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Major Depressive Disorder

Keywords

MDD; TMS; deep TMS

Outcome Measures

Primary Outcomes (3)

• Hamilton Rating Scale for Depression-17 (HRSD-17)

  score change. Higher score means worse outcome. (Min = 0, Max = 53)

  Baseline to Week 6

• Response (yes/no) on Hamilton Rating Scale for Depression-17

  Defined as a score reduction of 50% or more

  baseline to Week 6

• Remission (yes/no) on Hamilton Rating Scale for Depression-17

  Defined as a score of 7 or less

  Week 6

Secondary Outcomes (23)

• Hamilton Rating Scale for Depression-17

  Baseline to Week 7

• Hamilton Rating Scale for Depression-17

  Baseline to Week 10

• Hamilton Rating Scale for Depression-17

  Baseline to Week 18

• Response (yes/no) on Hamilton Rating Scale for Depression-17

  Baseline to Week 7

• Response (yes/no) on Hamilton Rating Scale for Depression-17

  Baseline to Week 10

Other Outcomes (4)

• Electroencephalogram to predict treatment response

  Baseline

• Electroencephalogram event-related potentials

  Baseline

• Electrocardiogram

  Baseline

Study Arms (2)

repetitive Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

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)

Device: transcranial magnetic stimulation

deep Transcranial Magnetic Stimulation

EXPERIMENTAL

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)

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

Participants will receive either rTMS or dTMS

Also known as: deep transcranial magnetic stimulation

deep Transcranial Magnetic Stimulation; repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

CHUM

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Jean-Philippe Miron, MD PhD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, single-center, two-arm, parallel-group superiority trial

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 13, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)