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

A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Encephalitis; Leucine-Rich Glioma Inactivated 1 Autoimmune 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Mei-Ping Ding; Phone Number: +86 0571 87783872; Email: dmp-neurology@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Chun-Hong Shen; Phone Number: +86 0571 87783872; Email: shen_neurology@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

the patients with anti-LGI1 encephalitis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory assessment 1	the Wechsler Memory Scale, high score means a good memory.	1 year, 2 year
Memory assessment 2	Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.	1 year, 2 year
Brain volume	with 3T magnetic resonance imaging (MRI), volumes of the whole hippocampus, hippocampal subfields and other relevant regions were determined using FreeSurfer. The unit of volume is described as mm3.	1 year, 2 year

Collaborators and Investigators

• Sponsor: Shen Chun-Hong
• Investigators: Principal Investigator: Chun-Hong Shen, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System
• Other Study ID Numbers: Y2022-0336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No