A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autoimmune Encephalitis, Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
Overview
Anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis has been increasingly identified as the second most common type of autoimmune encephalitis after anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. It presents with acute or subacute onset of epileptic seizures, anterograde amnesia, behavior disturbances, sleep disorders and hyponatremia. In most patients with anti-LGI1 encephalitis, immunotherapy is successful in treating the encephalitis. However, relapses, chronic epilepsy, cognitive declines and psychiatric problems have been reported in some cases. So far, prospective studies to evaluate its clinical outcomes still remain limited. In this project, the investigators will use clinical features and advanced paraclinical examinations to prospectively investigate the clinical outcomes and the associated factors in patients with anti-LGI1 encephalitis.
Detailed description
In this prospective study, the investigators are aiming to recruit newly diagnosed patients with anti-LGI1 encephalitis. At the acute stage and during the follow-up, some routine and advanced paraclinical examinations will be conducted, including dynamic blood and/or cerebrospinal fluid (CSF) test, multimodal brain magnetic resonance imaging (MRI) including functional MRI, diffusion tensor imaging, arterial spin labeling, et al), Electroencephalography (EEG) or continuous video-EEG (VEEG), positron emission tomography (PET), neuropsychological tests and some other paraclinical examinations. Through the comprehensive analysis, the clinical outcomes and associated factors are further explored in anti-LGI1 encephalitis.
Primary outcome measures
- seizure outcomes [Time frame: 1 year, 2 year]
- Clinical severity and recovery 1 [Time frame: 1 year, 2 year]
- Clinical severity and recovery 2 [Time frame: 1 year, 2 year]
- Incidence of recurrence [Time frame: 1 year, 2 year]
Secondary outcome measures (3)
- Memory assessment 1 [Time frame: 1 year, 2 year]
- Memory assessment 2 [Time frame: 1 year, 2 year]
- Brain volume [Time frame: 1 year, 2 year]
Eligibility criteria
Inclusion criteria
- Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis.
- Newly diagnosed, and during the acute stage before study enrollment.
- Sign the informed consent form.
Exclusion criteria
- with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis.
- with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody.
- Lost to follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou
Identifiers
NCT: NCT06173076 · Y2022-0336