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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Impairment, Autoimmune Encephalitis

Intervention / Treatment
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* Drug: rituximab
* Drug: cyclophosphamide
* Drug: Steroids
* Drug: Intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with first-line and second-line<br>patients who received intravenous second-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis),in addition to first-line immunotherapy (rituximab, cyclophosphamide) | Drug: rituximab<br>* 375 mg/m2 weekly for 4 weeks<br>* Other names: rituximab injection;Drug: cyclophosphamide<br>* 750 mg/m2 monthly for 4-6 cycles depending on the response<br>* Other names: cyclophosphamide injection;Drug: Steroids<br>* 500-1000 mg of methylprednisolone daily for 3 days, then tapered doses<br>* Other names: methylprednisolone;Drug: Intravenous immunoglobulin<br>* intravenous immunoglobulin (IVIG) with or without plasmapheresis<br>* Other names: IVIG;|
| patients with first-line only<br>patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only | Drug: Steroids<br>* 500-1000 mg of methylprednisolone daily for 3 days, then tapered doses<br>* Other names: methylprednisolone;Drug: Intravenous immunoglobulin<br>* intravenous immunoglobulin (IVIG) with or without plasmapheresis<br>* Other names: IVIG;|
| healthy control<br>healthy individuals without a history of psychiatric or neurologic disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain functional connectivity changes | The study uses multi-model fMRI to measure changes of functional connectivity across regions during recovery | a minimum of 6 months following initial discharge from hospital | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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episodic memory, executive control, fMRI