Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area (MuPRaNE)

May 10, 2015 updated by: Jia Wei Wang,MD
Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis,found in recent years,producing the specific IgG antibody induced by the NMDA receptors.It is the most common curable disease among the non infectious-autoimmune encephalitis,usually has been misdiagnosed as other causes of encephalitis.Our previous study found that there are differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as the sex ratio, the rate of combined tumor and clinical manifestations.As a new found disease,the incidence rate has been underestimated.Therefore,to establish the Registry Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This study will combine Beijing area's hospitals and foreign experts,depending on multicenter, prospective and registry method,to understand the incidence in Beijing area,to summarize and analyze the clinical data of patients.So,there will make a solid foundation for the subsequent Beijing area detection platform and other research.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

400

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

    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital,Capital Medical Universiy
        • Contact:

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

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The unexplained encephalitis patients in Beijing area

Description

Inclusion Criteria:

  • Older than 6 months.
  • Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
  • At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
  • Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear

Exclusion Criteria:

  • Infants less than 6 months;
  • The metabolic encephalopathy;
  • Infectious encephalitis with clinically clear pathogen, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
  • Non-infectious encephalitis with clinically clear diagnosis, including: multiple sclerosis, optic neuromyelitis, acute disseminated encephalomyelitis and so on.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

June 1, 2014

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 10, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 10, 2015

Last Verified

May 1, 2015

More Information

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.

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