To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI

Completed

• Conditions: Cognitive Impairment; Autoimmune Encephalitis
• Interventions: Drug: rituximab; Drug: cyclophosphamide; Drug: Steroids; Drug: Intravenous immunoglobulin

• Registration Number: NCT03530462
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-07
• Status Verified: 2018-02
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-05-07
• Last Update Submitted: 2018-05-07
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with first-line and second-line	rituximab	patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)
patient with first-line and second-line	Steroids	patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)
patient with first-line and second-line	Intravenous immunoglobulin	patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)
patients with first-line only	Steroids	patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only
patients with first-line only	Intravenous immunoglobulin	patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only
patient with first-line and second-line	cyclophosphamide	patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide)

Primary Outcome Measures

Name	Time	Method
brain functional connectivity changes	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 Outcome Measures

Name	Time	Method
emotion-depression	a minimum of 6 months following initial discharge from hospital	self-rating depression scale (SDS), the \*total\* range (20-80 scores), depression state (the total score is equal or above 41)
semantic fluency test	a minimum of 6 months following initial discharge from hospital	vegetable and fruit, animal
verbal episodic memory	a minimum of 6 months following initial discharge from hospital	Chinese auditory verbal learning test (CAVLT)
information processing speed	a minimum of 6 months following initial discharge from hospital	symbol-digit modalities test (SDMT)
emotion-anxiety	a minimum of 6 months following initial discharge from hospital	self-rating anxiety scale (SAS),the \*total\* range (20-80 scores), anxiety state (the total score is equal or above 41)
executive control	a minimum of 6 months following initial discharge from hospital	Stroop test
visual-spatial ability	a minimum of 6 months following initial discharge from hospital	block design test
non-verbal episodic memory	a minimum of 6 months following initial discharge from hospital	Aggie Figures Learning Test (AFLT)
working memory	a minimum of 6 months following initial discharge from hospital	working memory test

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China