NCT07324070

Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression

New Methods Electroconvulsive Therapy Augmentation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The RTMSECT2 study was design to compare the application of electroconvulsive therapy augmented by transcranial magnetic stimulation. Subject will be compared both within groups and in group using psychometric scales and different deliver energy

Detailed description

The study is monocentric, sham - controlled, randomized and triple blind (subjects, ECT and TMS practitioners, psychological assessment and outcome assessor). Subjects are randomized into two arms. The primary objective is to determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold. iTBS is administered with the shortest possible latency before the ECT procedure itself, ideally within two minutes of iTBS completion. The target site is the left DLPFC. The ECT dose is determined via a titration method to identify the lowest energy level required to elicit an epileptic seizure (seizure threshold). From the second session onwards, a stimulus intensity of 6 times the seizure threshold (6xST) is applied. Delivered energy is measured in percentage for TMS and ECT of the maximum charge that the devices are able to administer. In the event of inadequate seizure duration, the dose will be increased by 100% at the subsequent session. Primary outcome of the study is the overall apllied dose. Then Time to Recovery (TTR) is measured in minutes until fully awake. The subjects will be closely monitored throughout the entire ECT courses including psychometric scales. The MECTA SIGMA device will be used for ECT. The Deymed DuoMAG XT will be used for TMS/iTBS.

Conditions

• Major Depressive Disorder (MDD)
• Treatment Resistant Depression (TRD)

Interventions

Type	Name	Description
DEVICE	Electroconvulsive therapy	transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy
DEVICE	Transcranial Magnetic Stimulation	Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS

Timeline

• Start date: 2026-01-05
• Primary completion: 2028-01-05
• Completion: 2029-01-05
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study