Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression
NCT ID: NCT07324070
Last Updated: 2026-01-07
Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-05
2029-01-05
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Blue group
active group
Electroconvulsive therapy
transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy
Transcranial Magnetic Stimulation
Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS
Red group
Electroconvulsive therapy
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
Transcranial Magnetic Stimulation
Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS
Eligibility Criteria
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Inclusion Criteria
* MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20
* Major depressive disorder according to ICD 10
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Responsible Party
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Daniel Divácký
MD
Locations
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General University Hospital, Psychiatry department
Prague, Czech, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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102/25 S-IV Grant AP
Identifier Type: -
Identifier Source: org_study_id
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