Study of Electroconvulsive Therapy Combined with Transcranial Magnetic Stimulation for Treatment Resistant Depression

What this Trial Is About

Researchers are evaluating the use of electroconvulsive therapy ECT combined with transcranial magnetic stimulation TMS to treat people with major depressive disorder who have not responded to other treatments. This study is randomized, sham-controlled, and triple-blind, aiming to see if TMS priming before ECT can reduce the seizure threshold needed for ECT. The study focuses on measuring the overall applied energy dose and recovery times after treatment. Participants are randomly assigned to one of two groups, receiving either active TMS with ECT or sham TMS with ECT. TMS is given using the intermittent theta burst stimulation iTBS protocol targeting the left dorsolateral prefrontal cortex shortly before ECT, ideally within two minutes. ECT doses are set based on seizure threshold and adjusted if seizures are insufficient. The treatments use specific devices the MECTA SIGMA for ECT and the Deymed DuoMAG XT for TMSiTBS. During the study, participants are closely monitored with psychometric scales including MADRS, cognitive assessments, and memory tests at baseline, during treatment, and after the ECT course. Recovery time after each ECT session is measured in minutes. The study includes careful safety monitoring throughout the treatment period. The total duration of participation aligns with the ECT course and assessment schedule, ending within days after the final treatment.

Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression