A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis

NCT ID: NCT06173076

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2032-12-31

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.

Conditions

Autoimmune Encephalitis; Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shen Chun-Hong

OTHER

Sponsor Role: lead

Responsible Party

Shen Chun-Hong

Associate Senior Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chun-Hong Shen

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mei-Ping Ding

Role: CONTACT

dmp-neurology@zju.edu.cn

+86 0571 87783872

Facility Contacts

Chun-Hong Shen

Role: primary

shen_neurology@zju.edu.cn

+86 0571 87783872

Other Identifiers

Y2022-0336

Identifier Type: -

Identifier Source: org_study_id