Rouvray Hospital Center
Maud Rothärmel
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.
Major Depressive Disorder
Active rTMS
Sham rTMS
Not Applicable
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 |
Estimated Enrollment : | 80 participants |
Masking : | Triple |
Primary Purpose : | Treatment |
Official Title : | Clinical, Cognitive and Neural Effect of Potentiation of Electroconvulsive Therapy (ECT) by Repetitive Transcranial Magnetic Stimulation (rTMS) at 10 ECT in Patients With Characterized Pharmacoresistant Depressive Episode |
Actual Study Start Date : | June 2024 |
Estimated Primary Completion Date : | August 2026 |
Estimated Study Completion Date : | September 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Active rTMS group 5 active rTMS before starting ECT, then from the sixth ECT session, an active rTMS session will occur the day before each ECT session |
Device: Active rTMS |
Placebo Comparator: Sham rTMS group 5 sham rTMS before starting ECT, then from the sixth ECT session, a sham rTMS session will occur the day before each ECT session |
Device: Sham rTMS |
Ages Eligible for Study: | 18 Years to 70 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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