A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- seizure outcomes
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
seizure outcomes
Time Frame: 1 year, 2 year
The incidence of different seizure outcomes and associated factors will be analyzed.
Clinical severity and recovery 1
Time Frame: 1 year, 2 year
modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Clinical severity and recovery 2
Time Frame: 1 year, 2 year
clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome
Incidence of recurrence
Time Frame: 1 year, 2 year
a relapse of encephalitis
Secondary Outcomes
- Memory assessment 2(1 year, 2 year)
- Memory assessment 1(1 year, 2 year)
- Brain volume(1 year, 2 year)
Investigators
Shen Chun-Hong
Associate Senior Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University