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

Recruiting

• Conditions: Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis; Autoimmune Encephalitis

• Registration Number: NCT06173076
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2022-05-18
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Primary Completion: 2027-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
seizure outcomes	1 year, 2 year	The incidence of different seizure outcomes and associated factors will be analyzed.
Clinical severity and recovery 1	1 year, 2 year	modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Clinical severity and recovery 2	1 year, 2 year	clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome
Incidence of recurrence	1 year, 2 year	a relapse of encephalitis

Secondary Outcome Measures

Name	Time	Method
Memory assessment 2	1 year, 2 year	Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.
Memory assessment 1	1 year, 2 year	the Wechsler Memory Scale, high score means a good memory.
Brain volume	1 year, 2 year	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.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China