Multicenter and Prospective Clinical Registry Study of Autoimmune Encephalitis in China

NCT ID: NCT02561260

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31

Brief Summary

In recent years, more and more previously thought to be unknown encephalitis was found to be a specific antigen associated 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 autoimmune encephalitis in Chinese population. The prospective clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis associated antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of autoimmune encephalitis.

Conditions

Autoimmune Encephlitis in China

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

autoimmune encephalitis

No interventions assigned to this group

unknowm encephalitis

No interventions assigned to this group

other encephalopathy

No interventions assigned to this group

Eligibility Criteria

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 the 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

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

Jia Wei Wang,MD

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2014-1-1101-2

Identifier Type: -

Identifier Source: org_study_id