NCT02443350

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

May 10, 2015

Last Update Submit

May 10, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • death

    24 months

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The unexplained encephalitis patients in Beijing area

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital,Capital Medical Universiy

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Peng Y, Dai F, Liu L, Chen W, Yan H, Liu A, Zhang X, Wang X, He J, Li Y, Li C, Chen L, Zhao Y, Li L, Ma Q, Wang J. Validation of the NEOS score in Chinese patients with anti-NMDAR encephalitis. Neurol Neuroimmunol Neuroinflamm. 2020 Aug 5;7(5):e860. doi: 10.1212/NXI.0000000000000860. Print 2020 Sep.

MeSH Terms

Conditions

Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesAutoimmune Diseases of the Nervous SystemAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jia Wei Wang, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.;The head of Department of Neurology and Medical Research Center

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 13, 2015

Study Start

June 1, 2014

Primary Completion

May 1, 2017

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations