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

May 7, 2018 updated by: First Affiliated Hospital of Zhejiang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with autoimmune encephalitis and healthy control

Description

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

-

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
375 mg/m2 weekly for 4 weeks
Other Names:
  • rituximab injection
Drug: cyclophosphamide
750 mg/m2 monthly for 4-6 cycles depending on the response
Other Names:
  • cyclophosphamide injection
Drug: Steroids
500-1000 mg of methylprednisolone daily for 3 days, then tapered doses
Other Names:
  • methylprednisolone
Drug: Intravenous immunoglobulin
intravenous immunoglobulin (IVIG) with or without plasmapheresis
Other Names:
  • IVIG
patients with first-line only
patients who received first-line immunotherapy (steroids, intravenous immunoglobulin, plasmapheresis)only
Drug: Steroids
500-1000 mg of methylprednisolone daily for 3 days, then tapered doses
Other Names:
  • methylprednisolone
Drug: Intravenous immunoglobulin
intravenous immunoglobulin (IVIG) with or without plasmapheresis
Other Names:
  • IVIG
healthy control
healthy individuals without a history of psychiatric or neurologic disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
a minimum of 6 months following initial discharge from hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
verbal episodic memory
Time Frame: a minimum of 6 months following initial discharge from hospital
Chinese auditory verbal learning test (CAVLT)
a minimum of 6 months following initial discharge from hospital
non-verbal episodic memory
Time Frame: a minimum of 6 months following initial discharge from hospital
Aggie Figures Learning Test (AFLT)
a minimum of 6 months following initial discharge from hospital
working memory
Time Frame: a minimum of 6 months following initial discharge from hospital
working memory test
a minimum of 6 months following initial discharge from hospital
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)
a minimum of 6 months following initial discharge from hospital
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)
a minimum of 6 months following initial discharge from hospital
executive control
Time Frame: a minimum of 6 months following initial discharge from hospital
Stroop test
a minimum of 6 months following initial discharge from hospital
information processing speed
Time Frame: a minimum of 6 months following initial discharge from hospital
symbol-digit modalities test (SDMT)
a minimum of 6 months following initial discharge from hospital
visual-spatial ability
Time Frame: a minimum of 6 months following initial discharge from hospital
block design test
a minimum of 6 months following initial discharge from hospital
semantic fluency test
Time Frame: a minimum of 6 months following initial discharge from hospital
vegetable and fruit, animal
a minimum of 6 months following initial discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2017

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

March 18, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (ACTUAL)

May 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • multi-mode MRIs- encephalitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Impairment

Clinical Trials on rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe