Actively Recruiting
Electroconvulsive Therapy Augmented with Transcranial Magnetic Stimulation for Treatment-Resistant Depression
Led by Charles University, Czech Republic · Updated on 2026-01-07
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
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 TMS/iTBS. 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.
CONDITIONS
Brief Title
Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age equal to 18 or higher
- Montgomery-Asberg Depression Scale (MADRS) score of 20 or higher
- Diagnosis of major depressive disorder according to ICD 10
You will not qualify if you...
- Other axis 1 disorders such as schizophrenia or addiction
- Dementia
- Electroconvulsive therapy (ECT) in the last 3 months
- Transcranial magnetic stimulation (TMS) in the last 3 months
- Psychotic disease or symptoms
- Pregnancy or lactation
- Any neurological disease, including epilepsy
- Participation in another clinical trial within the last 30 days
- Somatic conditions that contraindicate ECT
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the duration of the ECT course (approximately several sessions over days)
Participants receive intermittent theta burst stimulation (iTBS) or sham TMS immediately before each electroconvulsive therapy (ECT) session as part of the treatment for treatment-resistant depression. The ECT dose is adjusted based on seizure threshold determined during the course.
Multiple visits corresponding to each ECT session with TMS priming
Duration - Within 2 days after completion of ECT course
Participants are monitored immediately after each ECT procedure and assessments are performed within 2 days after the course of ECT to evaluate recovery, cognitive function, and antidepressant response.
Approximately 1 to 2 visits post-treatment
Trial Site Locations
Total: 1 location
1
General University Hospital, Psychiatry department
Prague, Czech, Czechia, 120 39
Actively Recruiting
Research Team
D
Daniel Divacky
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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