New Methods Electroconvulsive Therapy Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- reduction of the seizure treshold of ECT
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to 18 or higher
- •MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20
- •Major depressive disorder according to ICD 10
排除标准
- •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
结局指标
主要结局
reduction of the seizure treshold of ECT
时间窗: during each ECT procedure
determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold
次要结局
- Time to Recovery (TTR)(immediately after each ECT procedure)
- speed of onset of antidepressant effect(T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4))
- 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)
- 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)
- AMI - SF (Autobiographical Memory Interview - short form)(T1: baseline, T3: after the course of ECT, within 2 days)
- 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)
- 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)
- MoCA (Montreal Cognitive Assessment)(T1: baseline, T3: after the course of ECT, within 2 days)
- TMT (trail making test)(T1: baseline, T3: after the course of ECT, within 2 days)
- RAVLT (The Rey Auditory Verbal Learning Test)(T1: baseline, T3: after the course of ECT, within 2 days)
研究者
Daniel Divácký
MD
Charles University, Czech Republic