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

NCT03530462 | Completed

• 1 other identifier: multi-mode MRIs- encephalitis
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Autoimmune Encephalitis

Keywords

episodic memory; executive control; fMRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• verbal episodic memory

  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

• emotion-anxiety

  a minimum of 6 months following initial discharge from hospital

• emotion-depression

  a minimum of 6 months following initial discharge from hospital

Study Arms (3)

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)

Drug: rituximab; Drug: cyclophosphamide; Drug: Steroids; Drug: Intravenous immunoglobulin

patients with first-line only

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

Drug: Steroids; Drug: Intravenous immunoglobulin

healthy control

healthy individuals without a history of psychiatric or neurologic disease

Interventions

rituximab DRUG

375 mg/m2 weekly for 4 weeks

Also known as: rituximab injection

patient with first-line and second-line

cyclophosphamide DRUG

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

Also known as: cyclophosphamide injection

patient with first-line and second-line

Steroids DRUG

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

Also known as: methylprednisolone

patient with first-line and second-line; patients with first-line only

Intravenous immunoglobulin DRUG

intravenous immunoglobulin (IVIG) with or without plasmapheresis

Also known as: IVIG

patient with first-line and second-line; patients with first-line only

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with autoimmune encephalitis and healthy control

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Autoimmune Diseases of the Nervous System

Interventions

Rituximab; Cyclophosphamide; Steroids; Methylprednisolone; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Fused-Ring Compounds; Polycyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Immunoglobulin G; Immunoglobulin Isotypes

Study Officials

• Benyan Luo, Ph.D

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: May 21, 2018
• Study Start: April 7, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)