Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Conditions
Brief summary
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
DEVICEElectroconvulsive therapy
transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy
DEVICETranscranial Magnetic Stimulation
Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of the seizure treshold of ECT | during each ECT procedure | determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| speed of onset of antidepressant effect | T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4) | according to MADRS |
| MADRS response rate to treatment | 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 | Percentage of participants experiencing a 50% decrease in MADRS |
| MADRS total response | 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 | change in total MADRS score |
| AMI - SF (Autobiographical Memory Interview - short form) | T1: baseline, T3: after the course of ECT, within 2 days | This scale is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT). |
| Time to Recovery (TTR) | immediately after each ECT procedure | The duration from ECT administration to the restoration of full consciousness, will be measured in minutes and assessed using a modified Glasgow Coma Scale. |
| ECCA (Electroconvulsive cognitive assesment) | 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 | cognitive scale optimized for patients undergoing ECT |
| MoCA (Montreal Cognitive Assessment) | T1: baseline, T3: after the course of ECT, within 2 days | screening test for cognitive functions, one of inclusion criteria of the study |
| TMT (trail making test) | T1: baseline, T3: after the course of ECT, within 2 days | psychometric test for evaluation of cisual-perceptual and executive functions |
| RAVLT (The Rey Auditory Verbal Learning Test) | T1: baseline, T3: after the course of ECT, within 2 days | Neuropsychological assessment designed to evaluate verbal memory in patients |
| QIDS (The Quick Inventory of Depressive Symptomatology) | 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 | scale for self - assessment of depressive symptoms |
Countries
Czechia
Contacts
Primary ContactDaniel Divacky
Outcome results
None listed