Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| Centre Hospitalier Sainte Anne, Paris | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS group | Active Comparator | 5 active rTMS before starting ECT, then from the sixth ECT session, an active rTMS session will occur the day before each ECT session |
|
| Sham rTMS group | Placebo Comparator | 5 sham rTMS before starting ECT, then from the sixth ECT session, a sham rTMS session will occur the day before each ECT session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 0 and Day 40 |
| Measure | Description | Time Frame |
|---|---|---|
| The relative improvement of depressive symptoms throughout the study (assessed by a clinician) | the relative variation of HAMD-21 | Day 0, Day 4, Day 19, Day 26, Day 40 |
| The relative improvement of depressive symptoms throughout the study (self-reported) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maud Rotharmel | Contact | +33232956825 | maud.rotharmel@ch-lerouvray.fr | |
| Virginie Moulier | Contact | virginie.moulier@ch-lerouvray.fr |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41582128 | Derived | Clabeau L, Moulier V, Kaczmarek B, Dalmont M, Batail JM, Bouaziz N, Brunelin J, Calvet B, Daudet C, Dollfus S, Domenech P, Drapier D, Galvao F, Gohier B, Harika-Germaneau G, Holtzmann J, Jaafari N, Jalenques I, Januel D, Kazour F, Laurin A, Letourneur F, Pouchon A, Samalin L, Sauvaget A, Szekely D, Vinckier F, Le Clezio C, Compere V, Gerardin E, Guillin O, Quesada P, Rotharmel M. A prospective multicentre double-blind randomized controlled trial evaluating clinical, cognitive and neural effects of potentiation of electroconvulsive therapy by repetitive transcranial magnetic stimulation in patients with treatment-resistant depression (STIMAGNECT 2). Trials. 2026 Jan 26;27(1):149. doi: 10.1186/s13063-025-09406-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Multicenter, randomized, double-blind, sham-controlled trial
Not provided
Not provided
Not provided
| Sham rTMS | Device | Sham rTMS will be administered over the left dorsolateral prefrontal cortex |
|
Quick Inventory of Depressive Symptomatology |
| 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) | 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) | 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) | Day 4, Day 19, Day 26, Day 40 |
| Global cognitive functioning (objective) | Scores and variations assessed with the Mini Mental Status Examination | Day 0 and Day 40 |
| Verbal memory performances (objective) | Scores and variations assessed with the RL/RI-16 test | Day 0 and Day 40 |
| Attention (objective) | Scores and variations assessed the D2 test of attention | Day 0 and Day 40 |
| Visuospatial and constructional ability (objective) | Scores and variations assessed with the Rey-Osterrieth complex figure test | Day 0 and Day 40 |
| Autobiographical memory (objective) | Scores and variations assessed with the autobiographical memory test (TEMPau) | Day 0 and Day 40 |
| Seizure threshold | Seizure threshold during ECT | 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 | 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 | 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 | 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 | Day 0 and Day 40 |
| Changes in cortical thickness | Changes in cortical thickness measured with 3D MRI | Day 0 and Day 40 |
| Brain activity and biochemical changes | Changes measured with Resting state functional MRI and spectroscopy MRI | Day 0 and Day 40 |