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Multicenter and Prospective Clinical Registry Study of Autoimmune Encephalitis in China

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ClinicalTrials.gov Identifier: NCT02561260
Recruitment Status : Unknown
Verified September 2015 by Jia Wei Wang,MD, Beijing Tongren Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2015
Last Update Posted : September 29, 2015
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Xuanwu Hospital, Beijing
Peking Union Medical College Hospital
Beijing Children's Hospital
Information provided by (Responsible Party):
Jia Wei Wang,MD, Beijing Tongren Hospital

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.

Condition or disease
Autoimmune Encephlitis in China

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Group/Cohort
autoimmune encephalitis
unknowm encephalitis
other encephalopathy



Primary Outcome Measures :
  1. death [ Time Frame: 30days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The unidentified encephalitis patients who meeting the inclusion criteria and exclusion criteria and signed a written informed consent.
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.

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Responsible Party: Jia Wei Wang,MD, Chairman and Full Professor of Department of Neurology and Medical Research Center, Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT02561260     History of Changes
Other Study ID Numbers: 2014-1-1101-2
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015