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

Autoimmune Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173076
• Other study ID #: Y2022-0336
• Status: Recruiting
• Start date: May 18, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: November 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Mei-Ping Ding
• Phone: +86 0571 87783872
• Email: dmp-neurology[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis
• Epilepsies, Partial
• Glioma
• Hashimoto Disease

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure outcomes	The incidence of different seizure outcomes and associated factors will be analyzed.	1 year, 2 year
Primary	Clinical severity and recovery 1	modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome	1 year, 2 year
Primary	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
Primary	Incidence of recurrence	a relapse of encephalitis	1 year, 2 year
Secondary	Memory assessment 1	the Wechsler Memory Scale, high score means a good memory.	1 year, 2 year
Secondary	Memory assessment 2	Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.	1 year, 2 year
Secondary	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