ReDeeMD: Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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) |
Device: transcranial magnetic stimulation
Participants will receive either rTMS or dTMS
Other Names:
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| Experimental: 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) |
Device: transcranial magnetic stimulation
Participants will receive either rTMS or dTMS
Other Names:
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Outcome Measures
Primary Outcome Measures
- Hamilton Rating Scale for Depression-17 (HRSD-17) [Baseline to Week 6]
score change. Higher score means worse outcome. (Min = 0, Max = 53)
- Response (yes/no) on Hamilton Rating Scale for Depression-17 [baseline to Week 6]
Defined as a score reduction of 50% or more
- Remission (yes/no) on Hamilton Rating Scale for Depression-17 [Week 6]
Defined as a score of 7 or less
Secondary Outcome Measures
- Hamilton Rating Scale for Depression-17 [Baseline to Week 7]
score change. Higher score means worse outcome. (Min = 0, Max = 53)
- Hamilton Rating Scale for Depression-17 [Baseline to Week 10]
score change. Higher score means worse outcome. (Min = 0, Max = 53)
- Hamilton Rating Scale for Depression-17 [Baseline to Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 53)
- Response (yes/no) on Hamilton Rating Scale for Depression-17 [Baseline to Week 7]
Defined as a score reduction of 50% or more
- Response (yes/no) on Hamilton Rating Scale for Depression-17 [Baseline to Week 10]
Defined as a score reduction of 50% or more
- Response (yes/no) on Hamilton Rating Scale for Depression-17 [Baseline to Week 18]
Defined as a score reduction of 50% or more
- Remission (yes/no) on Hamilton Rating Scale for Depression-17 [Baseline to Week 7]
Defined as a score of 7 or less
- Remission (yes/no) on Hamilton Rating Scale for Depression-17 [Baseline to Week 10]
Defined as a score of 7 or less
- Remission (yes/no) on Hamilton Rating Scale for Depression-17 [Baseline to Week 18]
Defined as a score of 7 or less
- Hamilton Rating Scale for Depression-28 [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 90)
- Hamilton Anxiety Rating Scale (HAM-A) [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 56)
- Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16) [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 42)
- General Anxiety Disorder-7 (GAD-7) [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 21)
- Snaith-Hamilton Pleasure Scale (SHAPS) [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min= 0, Max = 56)
- Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 30)
- Rumination Response Scale (RRS) [Baseline to Week 6, Week 7, Week 10, Week 18]
score change. Higher score means worse outcome. (Min = 0, Max = 88)
- Adult AHDH Self-Report Scale [Baseline to Week 18]
qualitative.
- McLean Screening Instrument for Borderline Personality Disorder [Baseline]
score. Higher score means worse outcome. (Min = 0, Max = 10)
- World Health Organization Quality of Life Short Version (WHOQOL-BREF) [Baseline to Week 6, Week 7, Week 10, Week 18]
Difference score. Lower score means worse outcome. (Min = 26, Max = 130)
- Cognitive Difficulties Scale (MacNair-R) [Baseline to Week 6, Week 7, Week 10, Week 18]
Difference score. Higher score means worse outcome. (Min = 0, Max = 156)
- Memory Complaints Scale (MacNair) [Baseline to Week 6, Week 7, Week 10, Week 18]
score. Higher score means worse outcome. (Min = 0, Max = 45)
- Sheehan Disability Scale [Baseline to Week 6, Week 7, Week 10, Week 18]
score. Higher score means worse outcome. (Min = 0, Max = 30)
- Visual Pain Scale [Each treatment day]
Maximum score (during treatment). Higher score means worse outcome. (Min = 0, Max = 10).
- Sex and Gender scale [Baseline]
Descriptive statistics
Other Outcome Measures
- Electroencephalogram to predict treatment response [Baseline]
individual alpha frequency
- Electroencephalogram event-related potentials [Baseline]
Reward positivity
- Electrocardiogram [Baseline]
corrected QT interval
- Neuro Cardiac Guided TMS [Baseline]
measure of heart rate deceleration to treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode
-
HRSD-17 score of at least 18
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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
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On a stable antidepressant regimen for the past four weeks before screening
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Patients with a chronic depressive episode >2 years and who have previously received ECT or ketamine will be eligible to participate
Exclusion Criteria:
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Having previously received TMS;
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Substance use disorder within the last three months
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Diagnosis of bipolar or psychosis spectrum disorder
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Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD
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Concomitant major unstable medical or neurological illness
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Intracranial implant, cardiac pacemaker or implanted medication pump
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Significant laboratory abnormality;
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Active suicidal intent
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Pregnancy
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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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: Jean-Philippe Miron, MD PhD, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2023-11389