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Clinical Trials/NCT03530462
NCT03530462
Completed
N/A

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 site in 1 country22 target enrollmentApril 7, 2017

Overview

Phase
N/A
Intervention
Steroids
Conditions
Cognitive Impairment
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
22
Locations
1
Primary Endpoint
brain functional connectivity changes
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 7, 2017
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

patients with first-line only

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

Intervention: Steroids

patients with first-line only

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

Intervention: Intravenous immunoglobulin

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)

Intervention: rituximab

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)

Intervention: cyclophosphamide

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)

Intervention: Steroids

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)

Intervention: Intravenous immunoglobulin

Outcomes

Primary Outcomes

brain functional connectivity changes

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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