Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression

NCT ID: NCT07324070

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2029-01-05

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Blue group

active group

Group Type EXPERIMENTAL

Electroconvulsive therapy

Intervention Type DEVICE

transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS

Red group

Group Type SHAM_COMPARATOR

Electroconvulsive therapy

Intervention Type DEVICE

transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy

Interventions

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Electroconvulsive therapy

transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy

Intervention Type DEVICE

Transcranial Magnetic Stimulation

Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Daniel Divácký

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General University Hospital, Psychiatry department

Prague, Czech, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Daniel Divacky

Role: CONTACT

+420 224 965 357

Facility Contacts

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Daniel Divacky

Role: primary

+ 420 224 965 357

Other Identifiers

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102/25 S-IV Grant AP

Identifier Type: -

Identifier Source: org_study_id

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