The Effect of 0.15ms Pulse Width on the Outcome of Electroconvulsive Therapy
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- BVMT-R (Brief Visuospatial Memory Test-Revised)
研究概览
简要总结
The PWECT015 study was designed to compare the application of 0.15ms and 0.30ms pulse width in electroconvulsive therapy (ECT). Subjects will be compared both within groups and in-group via psychometric scales.
详细描述
This study is a controlled randomized clinical trial. Patients (projected n=40 are randomized into two groups - blue (20) and red (20). Randomization will be blocked (size sample 4) - 1 allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers are blinded to what group the patients belong to and what ECT parameters are used. Patients and attending psychiatrists are also blinded as to which group the patient belongs to.
The MECTA SIGMA device will be used for ECT.
Cross-over titration by stimulation will be used during the application of ECT to find the seizure threshold (ST) as follows:
RED GROUP
- Session - Titration with 0.15ms
- Session - Titration with 0.3 ms
- Session and further - continue with 0.3 ms pulse width and 6x ST found during the second session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blocked randomization is used to divide patients into blue and red group via an allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers, patients and attending psychiatrists are blinded to what group the patients belong to and what ECT parameters are used.
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
- •score equal or higher than 20 on the Montgomery-Asberg Depression Scale (MADRS),
- •major depressive disorder or bipolar depression
排除标准
- •other axis 1 disorder
- •ECT in the last 3 months
- •neurological disease
- •psychosis
- •pregnancy
- •any somatic condition that contraindicates ECT
研究组 & 干预措施
Blue
- Session - Titration with 0.30ms pulse width
- Session - Titration with 0.15ms pulse width
- Session and further - continue with 0.15ms pulse width
干预措施: Electroconvulsive therapy (Device)
Red
- Session - Titration with 0.15ms pulse width
- Session - Titration with 0.3ms pulse width
- Session and further - continue with 0.3ms pulse width
干预措施: Electroconvulsive therapy (Device)
结局指标
主要结局
BVMT-R (Brief Visuospatial Memory Test-Revised)
时间窗: 1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course
Neuropsychological assessment designed to evaluate visuospatial memory in patients.
ECCA (Electroconvulsive cognitive assesment)
时间窗: T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days
cognitive screening optimized for measuring cognitive functions in patients before, during and after the course of ECT.
MoCA (Montreal Cognitive Assessment)
时间窗: T1: baseline, 2 days before the commencement of an ECT course, T2: 2 months after the ECT course, T3: 4 months after the ECT course, T4: 6 months after the ECT course
Screening of cognitive functions, results used as an inclusion criteria of the study and for the determination of the cognitive baseline.
MADRS (Montgomery-Asberg Depression Rating Scale)
时间窗: T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days, T4: 2 months after ECT , T5: 4 months after ECT, T6: 6 months after ECT
Assessment of depression severity, objective scale based on clinicians interview with a patient, results also used as an inclusion criteria of the study.
AMI (Autobiographical Memory Interview)
时间窗: T1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course
This interview is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT).
Time to Recovery (TTR)
时间窗: immediately after each ECT procedure, measured in minutes.
time to when the patient is fully vigilant and aware of his surroundings after an ECT procedure
QIDS (The Quick Inventory of Depressive Symptomatology)
时间窗: T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days, T4: 2 months after ECT , T5: 4 months after ECT, T6: 6 months after ECT
Rates depression symptoms via self-assessment
RAVLT (The Rey Auditory Verbal Learning Test)
时间窗: 1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course
Neuropsychological assessment designed to evaluate verbal memory in patients.
次要结局
未报告次要终点
研究者
Jozef Buday
Head of Neurostimulation Center, General University Hospital in Prague
Charles University, Czech Republic