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Completed

NCT Number: NCT03530462

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

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.

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Key information

Conditions

Cognitive Impairment Autoimmune Diseases Autoimmune Diseases of the Nervous System Autoimmune Encephalitis Cognition Disorders Cognitive Dysfunction Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Rituximab

Drug

375 mg/m2 weekly for 4 weeks

Other names: rituximab injection

Cyclophosphamide

Drug

750 mg/m2 monthly for 4-6 cycles depending on the response

Other names: cyclophosphamide injection

Steroids

Drug

500-1000 mg of methylprednisolone daily for 3 days, then tapered doses

Other names: methylprednisolone

intravenous immunoglobulin

Drug

intravenous immunoglobulin (IVIG) with or without plasmapheresis

Other names: IVIG

Primary outcomes

  1. 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

  1. verbal episodic memory

    Time frame: a minimum of 6 months following initial discharge from hospital

    Chinese auditory verbal learning test (CAVLT)

  2. non-verbal episodic memory

    Time frame: a minimum of 6 months following initial discharge from hospital

    Aggie Figures Learning Test (AFLT)

  3. working memory

    Time frame: a minimum of 6 months following initial discharge from hospital

    working memory test

  4. emotion-anxiety

    Time frame: 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)

  5. emotion-depression

    Time frame: 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)

  6. executive control

    Time frame: a minimum of 6 months following initial discharge from hospital

    Stroop test

  7. information processing speed

    Time frame: a minimum of 6 months following initial discharge from hospital

    symbol-digit modalities test (SDMT)

  8. visual-spatial ability

    Time frame: a minimum of 6 months following initial discharge from hospital

    block design test

  9. semantic fluency test

    Time frame: a minimum of 6 months following initial discharge from hospital

    vegetable and fruit, animal

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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