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临床试验/NCT03297411
NCT03297411Unknown2 期

Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

The University of New South Wales2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年10月10日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
15
试验地点
2
主要终点
HVLT-R

研究概览

简要总结

This study will generate new information on how to optimise brain targets with ECT stimulation.

详细描述

This study will differentiate the brain regions which are related to the effectiveness of electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4 different forms of ECT, which stimulate the brain differently; 2) in a subset of participants, use computer modelling to assess the pattern of brain stimulation with the 4 forms of ECT, and match these results to memory outcomes.

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
Double (Participant, Outcomes Assessor)

盲法说明

Both participants and the outcome assessor will be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥18 years; right-handed
  • DSM-5 Major Depressive Episode
  • Prescribed with a course of ECT

排除标准

  • Diagnosis (as defined by DSM-V) of psychotic disorder (apart from Major Depressive Episode with Psychotic features), current drug or alcohol abuse or dependence;
  • ECT treatments in last 3 months from a prior course of ECT;
  • Score <23 on the Montreal Cognitive Assessment Battery (MoCA);
  • Past or current neurological illness or injury, medical illness which may significantly affect neuropsychological function;
  • Inability to give informed consent or comply with study procedures; or
  • Not having worked or studied in an English speaking background (to ensure validity of neuropsychological testing).
  • Not be claustrophobic (if having an MRI brain scan).
  • Not have any metal in your head or body (if having an MRI brain scan).
  • Likely non response to RUL forms of ECT, as indicated by past non response to RUL ECT

研究组 & 干预措施

Brief Temporoparietal ECT

Active Comparator

Brief Pulse Temporoparietal ECT

干预措施: Brief Temporoparietal ECT (Procedure)

Ultrabrief Temporoparietal ECT

Active Comparator

Ultrabrief Pulse Temporoparietal ECT

干预措施: Ultrabrief Temporoparietal ECT (Procedure)

Brief Frontoparietal ECT

Active Comparator

Brief Pulse Frontoparietal ECT

干预措施: Brief Frontoparietal ECT (Procedure)

Ultrabrief Frontoparietal ECT

Active Comparator

Ultrabrief Pulse Frontoparietal ECT

干预措施: Ultrabrief Frontoparietal ECT (Procedure)

结局指标

主要结局

HVLT-R

时间窗: Approximately 30 min after ECT treatment

Hopkins Verbal Learning Test-Revised

BVMT-R

时间窗: Approximately 30 min after ECT treatment

Brief Visual Memory Test-Revised

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colleen Loo

Professor

The University of New South Wales

研究点 (2)

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