Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in China

Anti-NMDA receptor encephalitis is the most common curable non-infectious autoimmune encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of anti-NMDA receptor encephalitis in Chinese population. The multi-center, prospective clinical trial of anti-NMDA receptor encephalitis in China's , combined with Beijing Xuanwu hospital, Beijing Tiantan Hospital, Beijing Children's Hospital and other hospitals around the country, by screening the NMDA receptor antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of anti-NMDA receptor encephalitis.

Study Overview

• Status: Unknown
• Conditions: Anti-NMDA Receptor Enphalitis

• Study Type: Observational
• Enrollment (Anticipated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the unidentified encephalitis patients who meeting the inclusion criteria and exclusion criteria and signing the written informed consent form。

Description

Inclusion Criteria:

1. Older than 6 months.
2. Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
3. 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;
4. Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear.
5. Signed informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
anti-NMDA receptor encephalitis
other autoimmune encephlitis
other encephalopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
death	30 days

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: Peking Union Medical College Hospital; Beijing Tiantan Hospital; Xuanwu Hospital, Beijing; Beijing Children's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ANTICIPATED): May 1, 2017

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (ESTIMATE): September 24, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 27, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2014-1-1101-1