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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06173076
Enrollment
60
Registered
2023-12-15
Start date
2022-05-18
Completion date
2032-12-31
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalitis, Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

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.

Interventions

None listed

Sponsors

Shen Chun-Hong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
seizure outcomes1 year, 2 yearThe incidence of different seizure outcomes and associated factors will be analyzed.
Clinical severity and recovery 11 year, 2 yearmodified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Clinical severity and recovery 21 year, 2 yearclinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome
Incidence of recurrence1 year, 2 yeara relapse of encephalitis

Secondary

MeasureTime frameDescription
Memory assessment 21 year, 2 yearRey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.
Brain volume1 year, 2 yearwith 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.
Memory assessment 11 year, 2 yearthe Wechsler Memory Scale, high score means a good memory.

Countries

China

Contacts

Primary ContactMei-Ping Ding
dmp-neurology@zju.edu.cn+86 0571 87783872

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026