Autoimmune EncephalitisNCT06173076
A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
An observational study of Autoimmune Encephalitis and Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis, run by Shen Chun-Hong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Autoimmune Encephalitis, Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2022to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with anti-LGI1 encephalitis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
Chun-Hong Shen, +86 0571 87783872, shen_neurology@zju.edu.cn
About this study
Official title: A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 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.
Read the 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.
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure outcomes
The incidence of different seizure outcomes and associated factors will be analyzed.
Measured: 1 year, 2 year
Clinical severity and recovery 1
modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Measured: 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
Measured: 1 year, 2 year
Incidence of recurrence
a relapse of encephalitis
Measured: 1 year, 2 year
Secondary outcomes (3)
Memory assessment 1
the Wechsler Memory Scale, high score means a good memory.
Measured: 1 year, 2 year
Memory assessment 2
Rey Auditory Verbal Learning Test (RAVLT), high score means a good vebal episodic memory.
Measured: 1 year, 2 year
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.
Measured: 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start18 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Chun-Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Chun-Hong, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Chun-Hong Shen, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173076
- Sponsor's protocol ID
- Y2022-0336
- Status last verified
- Aug 2025
- First submitted
- 14 Nov 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
- ClinicalTrials.gov ID
- NCT06173076
- Acronym / sponsor ID
- Y2022-0336
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shen Chun-HongUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with anti-LGI1 encephalitis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Memory assessment 1
Time frame: 1 year, 2 year
Memory assessment 2
Time frame: 1 year, 2 year
Brain volume
Time frame: 1 year, 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Hong Shen principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis and Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis, run by Shen Chun-Hong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei-Ping Ding (+86 0571 87783872, dmp-neurology@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure outcomes (time frame: 1 year, 2 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.