Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. In this multicenter, randomized, double-blind, sham-controlled study, our objective is to assess the priming effect of rTMS sessions before ECT on clinical, cognitive and neural response in patients with TRD.
80 patients with TRD will be assigned to active or sham rTMS before ECT treatment. Five sessions of active/sham rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) before ECT (which was active for all patients) started. Then, from the sixth ECT session, an rTMS session will occur the day before each ECT session. Clinical assessment, cognitive assessment and brain imaging (structural MRI, resting state functional MRI, MR spectroscopy) will take place before and after 10 ECT sessions. Clinical, cognitive and neural changes will be compared between both groups after 10 ECT sessions. The primary outcome will be the response rate after 10 ECT, i.e. the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session)
Sham rTMS will be administered over the left dorsolateral prefrontal cortex
Response rate after 10 ECT
the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items)
Time frame: Day 0 and Day 40
The relative improvement of depressive symptoms throughout the study (assessed by a clinician)
the relative variation of HAMD-21
Time frame: Day 0, Day 4, Day 19, Day 26, Day 40
The relative improvement of depressive symptoms throughout the study (self-reported)
Quick Inventory of Depressive Symptomatology
Time frame: Day 0, Day 4, Day 19, Day 26, Day 40
Adverse effects
Assessment of adverse effects with the Udvalg for Kliniske Undersogelser (UKU) side effects rating scale adapted to rTMS (adapted UKU)
Time frame: Day 4, Day 19, Day 26, Day 40
Subjective assessment of memory
Scores and variations in memory assessed with the Squire Subjective Memory Questionnaire (SSMQ)
Time frame: Day 4, Day 19, Day 26, Day 40
Subjective assessment of cognitive functioning
Scores and variations in cognitive functioning assessed with the Cognitive Failures Questionnaire (CFQ)
Time frame: Day 4, Day 19, Day 26, Day 40
Global cognitive functioning (objective)
Scores and variations assessed with the Mini Mental Status Examination
Time frame: Day 0 and Day 40
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Verbal memory performances (objective)
Scores and variations assessed with the RL/RI-16 test
Time frame: Day 0 and Day 40
Attention (objective)
Scores and variations assessed the D2 test of attention
Time frame: Day 0 and Day 40
Visuospatial and constructional ability (objective)
Scores and variations assessed with the Rey-Osterrieth complex figure test
Time frame: Day 0 and Day 40
Autobiographical memory (objective)
Scores and variations assessed with the autobiographical memory test (TEMPau)
Time frame: Day 0 and Day 40
Seizure threshold
Seizure threshold during ECT
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Seizure duration
Seizure duration during ECT
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Postictal Suppression
Postictal Suppression during ECT
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Dose of medication
Dose of medication during ECT
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Changes in regional gray matter density
Changes in regional gray matter density measured with 3D MRI
Time frame: Day 0 and Day 40
Changes in cortical thickness
Changes in cortical thickness measured with 3D MRI
Time frame: Day 0 and Day 40
Brain activity and biochemical changes
Changes measured with Resting state functional MRI and spectroscopy MRI
Time frame: Day 0 and Day 40