Clinical trial NCT03530462: To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI
Official title: The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Autoimmune Encephalitis
Keywords: episodic memory
executive control
fMRI
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with autoimmune encephalitis and healthy control

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: brain functional connectivity changes
timeFrame: a minimum of 6 months following initial discharge from hospital
Secondary outcomes:
measure: verbal episodic memory
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: non-verbal episodic memory
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: working memory
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: emotion-anxiety
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: emotion-depression
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: executive control
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: information processing speed
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: visual-spatial ability
timeFrame: a minimum of 6 months following initial discharge from hospital
measure: semantic fluency test
timeFrame: a minimum of 6 months following initial discharge from hospital
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Benyan Luo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: