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临床试验/NCT02715986
NCT02715986已完成不适用

Structural-functional Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy: an Exploratory Study

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Morphological changes in the hippocampus between baseline and after the first ECT effective session as assessed by volume measure in multimodal MRI.

研究概览

简要总结

Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant depression whose effectiveness has been demonstrated. However, the brain mechanisms underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of glial cells. In addition, functional imaging of "resting state" type have shown, among depressed patients after ECT, increased functional connectivity . These results were reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it seems appropriate to continue research neuroanatomical correlates subtending neurofunctional processes responsible at the same time improving the clinical depressive. The investigators suggest using an original technique never used in this type of population: Functional magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow us to study the impact of ECT on brain structures involved in major depressive disorder: hippocampus.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnostic and Statistical Manual of Mental Disorders-V (DSM) diagnosis of major depressive disorder
  • •indication of ECT and signing the consent for conducting a ECT
  • •right-handed
  • •be of French mother tongue
  • •belong to a social security scheme
  • •sign an informed consent

排除标准

  • •against indication for MRI
  • •against indication to anesthesia
  • •processes brain expensive
  • •pregnant woman
  • •refuse to be informed of an abnormality detected during MRI
  • •Patients holders of stimulation electrodes
  • •presence history of neurological disease
  • •presence history of head injury
  • •Mini-Mental State Examination (MMSE) <15/30
  • •presence of neurodegenerative disease
  • •patients who have had ECT treatment in the last 6 months

研究组 & 干预措施

Severly depressed patients

Experimental

Recruitment of twenty depressive subjects will be conducted within the hospital service adult psychiatry.These patients are referred for indication of ECT sessions for severe resistant depression. Four MRI evaluations (3T MRI examination) are programmed in such patients to analyze structural changes in the hippocampus.

干预措施: 3T MRI (Device)

结局指标

主要结局

Morphological changes in the hippocampus between baseline and after the first ECT effective session as assessed by volume measure in multimodal MRI.

时间窗: Within 48 hours after the first effective ECT session.

Visit 3 will take place within 48 hours after the first ECT session effective.

次要结局

  • Functional connectivity changes of the hippocampus-related networks between baseline and after the first effective ECT session as assessed by measure of connectivity in multimodal MRI.(Within 48 hours after the first effective ECT session.)
  • Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by measure of volume in multimodal MRI.(Within 48 hours after the first ECT session.)
  • Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by average diffusivity in multimodal MRI.(Within 48 hours after the first ECT session.)
  • Functional changes of the hippocampal-related networks between baseline and after the first ECT session as assessed by measure of connectivity in multimodal MRI.(Within 48 hours after the first ECT session.)
  • Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by(Within 10 days after remission.)
  • Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by measure of volume in multimodal MRI(Within 10 days after remission.)
  • Functional changes in the hippocampus and hippocampal-related networks related to ECT after remission as assessed by measure of connectivity in multimodal MRI.(Within 10 days after remission)
  • Changes in the intensity of depressive symptoms score (Hamilton Depression Rating Scale) after the first ECT, ECT first "effective" and after remission(Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission)
  • Evolution of Real Life/Real Impact-16 (RLRI-16) score after the first ECT, after ECT first "effective" and after remission(Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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