2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Location status: Recruiting
Recruiting
NCT Number: NCT06173076
A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Primary outcomes
-
seizure outcomes
Time frame: 1 year, 2 year
The incidence of different seizure outcomes and associated factors will be analyzed.
-
Clinical severity and recovery 1
Time frame: 1 year, 2 year
modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
-
Clinical severity and recovery 2
Time frame: 1 year, 2 year
clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome
-
Incidence of recurrence
Time frame: 1 year, 2 year
a relapse of encephalitis
Secondary outcomes
-
Memory assessment 1
Time frame: 1 year, 2 year
the Wechsler Memory Scale, high score means a good memory.
-
Memory assessment 2
Time frame: 1 year, 2 year
Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.
-
Brain volume
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shen Chun-Hong
Other
Registry information
Official study title
A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
Important dates
- Study start
- 2022
- Primary completion
- 2027
- Study completion
- 2032
- First posted
- Dec 15, 2023
- Registry last updated
- Aug 27, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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