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

Charles University, Czech Republic

Status: Enrolling

Conditions: Treatment Resistant Depression (TRD); Major Depressive Disorder (MDD)

Treatments: Device: Transcranial Magnetic Stimulation; Device: Electroconvulsive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07324070

102/25 S-IV Grant AP

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Blue group

Experimental group

Description:

active group

Treatment:

Device: Electroconvulsive therapy

Device: Transcranial Magnetic Stimulation

Red group

Sham Comparator group

Treatment:

Device: Electroconvulsive therapy