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临床试验/NCT03530462
NCT03530462已完成不适用

The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年4月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
brain functional connectivity changes

研究概览

简要总结

Most of patients with autoimmune encephalitis are left with permanent cognitive deficits of varying severity. The patients' life and career would be affected definitely by cognitive deficits. Recently, more and more clinical physician have begun to focus on cognitive impairment of patients with autoimmune encephalitis. Generally, the outcome was measured by the modified Rankin Scale (mRS). However, the mRS are commonly used to evaluate the degree of disability or dependence in the daily activities of the patients suffering from a stroke and cognition function were minimally evaluated in this scale. It is crucial to adopt detailed cognition tools to study the long-term cognitive outcomes and as an indicator of overall curative effect judgment in autoimmune encephalitis.

Currently, only early immunotherapy is uniformly and consistently considered to produce favorable cognitive outcomes. However, studies concerning the association of second-line immunotherapy with cognitive outcomes have been scarce and have shown conflicting results regarding autoimmune encephalitis.

Hence, the goal of this study was to explore cognitive neural mechanism of autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs.

详细描述

The goal of this study was to explore cognitive neural mechanism of different types of autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs. Neuropsychological tests involves the assessments of different cognitive domains. And multi-mode MRIs contains resting-fMRI, DTI and task-related fMRI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis was established in all patients based on characteristic clinical presentation and detection of immunoglobulin G (IgG) antibodies.

排除标准

  • age >60 years or <16 years
  • notable lesions, such as tumors, scars, or vascular malformations, on brain MRI
  • a history of other neuropsychiatric disorders. -

研究组 & 干预措施

patients with first-line only

patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only

干预措施: Steroids (Drug)

patients with first-line only

patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only

干预措施: Intravenous immunoglobulin (Drug)

patient with first-line and second-line

patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)

干预措施: rituximab (Drug)

patient with first-line and second-line

patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)

干预措施: cyclophosphamide (Drug)

patient with first-line and second-line

patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)

干预措施: Steroids (Drug)

patient with first-line and second-line

patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)

干预措施: Intravenous immunoglobulin (Drug)

结局指标

主要结局

brain functional connectivity changes

时间窗: a minimum of 6 months following initial discharge from hospital

The study uses multi-model fMRI to measure changes of functional connectivity across regions during recovery

次要结局

  • emotion-depression(a minimum of 6 months following initial discharge from hospital)
  • semantic fluency test(a minimum of 6 months following initial discharge from hospital)
  • verbal episodic memory(a minimum of 6 months following initial discharge from hospital)
  • information processing speed(a minimum of 6 months following initial discharge from hospital)
  • emotion-anxiety(a minimum of 6 months following initial discharge from hospital)
  • executive control(a minimum of 6 months following initial discharge from hospital)
  • visual-spatial ability(a minimum of 6 months following initial discharge from hospital)
  • non-verbal episodic memory(a minimum of 6 months following initial discharge from hospital)
  • working memory(a minimum of 6 months following initial discharge from hospital)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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