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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue group | Experimental | active group |
|
| Red group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive therapy | Device | transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of the seizure treshold of ECT | determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold | during each ECT procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recovery (TTR) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Divacky | Contact | +420 224 965 357 | daniel.divacky@lf1.cuni.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital, Psychiatry department | Recruiting | Prague | Czech | 120 39 | Czechia |
Individual participant data can be shared when requested from a verified researcher
Data will be available after the end of the study
request by a verified researcher only
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| Transcranial Magnetic Stimulation | Device | Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS |
|
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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | Neuropsychological assessment designed to evaluate verbal memory in patients | T1: baseline, T3: after the course of ECT, within 2 days |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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