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

NCT ID: NCT02559089

Last Updated: 2015-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anti-NMDA Receptor Enphalitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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anti-NMDA receptor encephalitis

No interventions assigned to this group

other autoimmune encephlitis

No interventions assigned to this group

other encephalopathy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jia Wei Wang,MD

Chairman and Full Professor of Department of Neurology and Medical Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2014-1-1101-1

Identifier Type: -

Identifier Source: org_study_id

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