Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression (RMTSECT2)

January 6, 2026 updated by: Daniel Divácký, Charles University, Czech Republic

New Methods Electroconvulsive Therapy Augmentation

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Czech
      • Prague, Czech, Czechia, 120 39
        • Recruiting
        • General University Hospital, Psychiatry department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blue group
active group
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
Sham Comparator: Red group
Device: Electroconvulsive therapy
transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of the seizure treshold of ECT
Time Frame: during each ECT procedure
determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold
during each ECT procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recovery (TTR)
Time Frame: immediately after each ECT procedure
The duration from ECT administration to the restoration of full consciousness, will be measured in minutes and assessed using a modified Glasgow Coma Scale.
immediately after each ECT procedure
speed of onset of antidepressant effect
Time Frame: T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4)
according to MADRS
T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4)
MADRS response rate to treatment
Time Frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
Percentage of participants experiencing a 50% decrease in MADRS
T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
MADRS total response
Time Frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
change in total MADRS score
T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
AMI - SF (Autobiographical Memory Interview - short form)
Time Frame: T1: baseline, T3: after the course of ECT, within 2 days
This scale is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT).
T1: baseline, T3: after the course of ECT, within 2 days
QIDS (The Quick Inventory of Depressive Symptomatology)
Time Frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
scale for self - assessment of depressive symptoms
T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
ECCA (Electroconvulsive cognitive assesment)
Time Frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
cognitive scale optimized for patients undergoing ECT
T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
MoCA (Montreal Cognitive Assessment)
Time Frame: T1: baseline, T3: after the course of ECT, within 2 days
screening test for cognitive functions, one of inclusion criteria of the study
T1: baseline, T3: after the course of ECT, within 2 days
TMT (trail making test)
Time Frame: T1: baseline, T3: after the course of ECT, within 2 days
psychometric test for evaluation of cisual-perceptual and executive functions
T1: baseline, T3: after the course of ECT, within 2 days
RAVLT (The Rey Auditory Verbal Learning Test)
Time Frame: T1: baseline, T3: after the course of ECT, within 2 days
Neuropsychological assessment designed to evaluate verbal memory in patients
T1: baseline, T3: after the course of ECT, within 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

January 5, 2028

Study Completion (Estimated)

January 5, 2029

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102/25 S-IV Grant AP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data can be shared when requested from a verified researcher

IPD Sharing Time Frame

Data will be available after the end of the study

IPD Sharing Access Criteria

request by a verified researcher only

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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