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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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