Relapse and Functional Outcomes in Anti-LGI1 Encephalitis

NCT07722286 | Completed

• 1 other identifier: 2024-0682
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on a rare brain disease called anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. In this condition, the body's immune system mistakenly attacks a protein in the brain, which can cause problems with memory, thinking, behavior, and seizures. While most patients get better with initial treatments, some continue to have long-term symptoms or experience a return of the disease (called a "relapse") months or years later. The goal of this study is to understand how often these relapses and long-term problems happen and to identify which patients are most at risk. The investigators will look back at the medical records of patients diagnosed with anti-LGI1 encephalitis at five major hospitals in Eastern China. The information about their symptoms, the treatments they received and how they recovered over time are obtained. Then, the investigators will analyze this information to find out what factors are linked to having a relapse or a poor long-term recovery. By understanding the risks for relapse and poor outcomes, doctors can better identify which patients need closer monitoring and more long-term treatment strategies. The results of this study will help create better guidelines for managing patients with this disease after their initial recovery, aiming to improve their quality of life in the long run.

Conditions

Autoimmune Encephalitis; LGI1 Encephalitis; Limbic Encephalitis

Keywords

Anti-LGI1 Encephalitis; Relapse; Seizure recurrence; Risk factor

Outcome Measures

Primary Outcomes (1)

• Relapse

  the presence of new or worsening clinical features after at least 3 months of stability or improvement

  Through study completion, with the last follow-up date in January 2026

Secondary Outcomes (1)

• Functional outcomes

  Through study completion, with the last follow-up date in January 2026

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients at five tertiary medical centers from four cities in Eastern China (Second Affiliated Hospital of Zhejiang University School of Medicine, Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Shaoxing People's Hospital, Ningbo Medical Center Lihuili Hospital, and Huzhou Third People's Hospital)

You may qualify if:

• Characteristic presentations of anti-LGI1 encephalitis;
• LGI1-immunoglobulin G (IgG) positivity in serum and/or cerebrospinal fluid (CSF) by fixed cell-based assay (Euroimmun, Lübeck, Germany)
• follow-up ≥ 18 months after initial immunotherapies

You may not qualify if:

• presence of coexisting neural autoantibodies
• history of central nervous system (CNS) infections, severe neurological or primary psychiatric disorders
• no prior use or lack of first-line immunotherapy
• insufficient follow-up data

Sponsors & Collaborators

• Shen Chun-Hong: lead
• Sir Run Run Shaw Hospital: collaborator
• Shaoxing People's Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Huzhou Third People's Hospital: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; Limbic Encephalitis; Recurrence

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Encephalitis; Brain Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: July 23, 2026
• Study Start: January 1, 2015
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

CN (1)