Electroconvulsive therapy combined with transcranial magnetic stimulation for treatment-resistant depression
Official title: New Methods Electroconvulsive Therapy Augmentation
Run by Charles University, Czech Republic · NCT07324070 · Data updated 2026-11-12
This will test whether giving a short burst of intermittent theta-burst magnetic stimulation (iTBS) just before electroconvulsive therapy helps adults with treatment-resistant major depressive disorder by lowering the energy needed to trigger a therapeutic seizure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague, Czech) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | January 5, 2028 |
| Study ends | January 5, 2029 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07324070 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with major depressive disorder meeting ICD-10 criteria, a MADRS score ≥20, and treatment-resistant depression who have not had ECT or TMS in the past three months and who have no major contraindications to ECT or TMS are ideal candidates.
✕Probably not a fit
People with other primary Axis I disorders (for example schizophrenia or active substance dependence), psychotic symptoms, recent ECT/TMS, pregnancy or lactation, epilepsy or other contraindicating neurological or somatic conditions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, triple-blind, sham-controlled study randomizes adults with treatment-resistant major depressive disorder to receive either active iTBS priming of the left dorsolateral prefrontal cortex or sham stimulation immediately before electroconvulsive therapy (ECT). The main goal is to measure whether iTBS reduces the seizure threshold as determined by a titration method and to compare the overall delivered ECT and TMS energy between groups. From the second ECT session onwards, stimulus intensity is set at six times the identified seizure threshold, with dose escalations if seizure duration is inadequate. Outcomes include applied device energy, time to recovery after ECT, and psychometric scales collected across the ECT course; MECTA SIGMA and Deymed DuoMAG XT devices are used.
Why it matters
Potential benefit: If successful, the approach could allow effective ECT at lower electrical doses, potentially reducing cognitive side effects and improving recovery after treatment.
How similar studies have gone: Prior research on using TMS as a priming technique before ECT is limited and mixed, with small studies suggesting possible effects on seizure threshold but without large-scale replication.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age equal to 18 or higher * MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20 * Major depressive disorder according to ICD 10 Exclusion Criteria: * Other axis 1 disorder (for example schizofrenia, addiction, etc.) * No dementia * ECT in the last 3 months * TMS in the last 3 months * Psychotic disease or symptoms * Ppregnancy or lactation * Any neurological disease (for example epilepsy, etc.) * Participation in another clinical trial within the last 30 days * somatic condition which contraindicates ECT
Where it's running
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General University Hospital, Psychiatry department
Prague, Czech, Czechia Recruiting
Study contacts
- Study coordinator: Daniel Divacky
- Email: daniel.divacky@lf1.cuni.cz
- Phone: +420 224 965 357
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.