Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroconvulsive therapy, Transcranial Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
New Methods Electroconvulsive Therapy Augmentation
Overview
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.
Interventions
- 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
Primary outcome measures
- reduction of the seizure treshold of ECT [Time frame: during each ECT procedure]
Secondary outcome measures (10)
- Time to Recovery (TTR) [Time frame: 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)]
- 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]
- 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]
- AMI - SF (Autobiographical Memory Interview - short form) [Time frame: 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]
- 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]
- MoCA (Montreal Cognitive Assessment) [Time frame: 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]
- RAVLT (The Rey Auditory Verbal Learning Test) [Time frame: T1: baseline, T3: after the course of ECT, within 2 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- General University Hospital, Psychiatry department — Prague
Identifiers
NCT: NCT07324070 · 102/25 S-IV Grant AP