Clinical trial NCT06173076: A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
Official title: A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Encephalitis
Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients with anti-LGI1 encephalitis

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.

Eligibility criteria: Inclusion Criteria:

1. Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis.
2. Newly diagnosed, and during the acute stage before study enrollment.
3. Sign the informed consent form.

Exclusion Criteria:

1. with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis.
2. with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody.
3. Lost to follow-up.

Primary outcomes:
measure: seizure outcomes
timeFrame: 1 year, 2 year
measure: Clinical severity and recovery 1
timeFrame: 1 year, 2 year
measure: Clinical severity and recovery 2
timeFrame: 1 year, 2 year
measure: Incidence of recurrence
timeFrame: 1 year, 2 year
Secondary outcomes:
measure: Memory assessment 1
timeFrame: 1 year, 2 year
measure: Memory assessment 2
timeFrame: 1 year, 2 year
measure: Brain volume
timeFrame: 1 year, 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Chun-Hong Shen
role: PRINCIPAL_INVESTIGATOR
References: