A Prospective Study to Evaluate Clinical Outcomes in Anti... | NCT06173076

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

NCT06173076

Sponsor

Shen Chun-Hong

Status

Recruiting

Last Update Posted

Aug 27, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Autoimmune Encephalitis
Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Dec 7, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2025

Last Update Posted Date

Aug 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shen Chun-Hong, Associate Senior Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang UniversitySponsor-Investigator

Lead Sponsor

Shen Chun-HongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

the patients with anti-LGI1 encephalitis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mei-Ping Ding	Contact	+86 0571 87783872		dmp-neurology@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Chun-Hong Shen	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Recruiting	Hangzhou	Zhejiang		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020274	Autoimmune Diseases of the Nervous System

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided