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

NCT06173076 | Recruiting

• 1 other identifier: Y2022-0336
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis; Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Outcome Measures

Primary Outcomes (4)

• seizure outcomes

  The incidence of different seizure outcomes and associated factors will be analyzed.

  1 year, 2 year

• Clinical severity and recovery 1

  modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome

  1 year, 2 year

• Clinical severity and recovery 2

  clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome

  1 year, 2 year

• Incidence of recurrence

  a relapse of encephalitis

  1 year, 2 year

Secondary Outcomes (3)

• Memory assessment 1

  1 year, 2 year

• Memory assessment 2

  1 year, 2 year

• Brain volume

  1 year, 2 year

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients with anti-LGI1 encephalitis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shen Chun-Hong: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and cerebrospinal fluid samples will be stored to test antibodies, cytokines, immune cells and other relevant molecules. And patients have the right to destroy them at any time.

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chun-Hong Shen

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Ping Ding

CONTACT

+86 0571 87783872; dmp-neurology@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Senior Doctor

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 15, 2023
• Study Start: May 18, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)