Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Electroconvulsive therapy, Transcranial Magnetic Stimulation.
- Кому может быть актуально
- Состояния в реестре: Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Чехия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
New Methods Electroconvulsive Therapy Augmentation
Обзор
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
Подробное описание
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.
Вмешательства
- Устройство Electroconvulsive therapy
transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy - Устройство Transcranial Magnetic Stimulation
Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS
Первичные конечные точки
- reduction of the seizure treshold of ECT [Срок оценки: during each ECT procedure]
Вторичные конечные точки (10)
- Time to Recovery (TTR) [Срок оценки: immediately after each ECT procedure]
- speed of onset of antidepressant effect [Срок оценки: T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4)]
- MADRS response rate to treatment [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: T1: baseline, T3: after the course of ECT, within 2 days]
- QIDS (The Quick Inventory of Depressive Symptomatology) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: T1: baseline, T3: after the course of ECT, within 2 days]
- TMT (trail making test) [Срок оценки: T1: baseline, T3: after the course of ECT, within 2 days]
- RAVLT (The Rey Auditory Verbal Learning Test) [Срок оценки: T1: baseline, T3: after the course of ECT, within 2 days]
Критерии участия
Критерии включения
- Age equal to 18 or higher
- MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20
- Major depressive disorder according to ICD 10
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Чехия · 1 центр
- General University Hospital, Psychiatry department — Prague
Идентификаторы
NCT: NCT07324070 · 102/25 S-IV Grant AP