ClinicalTrials.gov record NCT06173076
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study follows people newly diagnosed with anti-LGI1 autoimmune encephalitis during the acute stage. Investigators will collect clinical data and perform tests including blood and/or cerebrospinal fluid samples, multimodal brain MRI, EEG or continuous video-EEG, PET scans, and neuropsychological tests. The study will track seizures, functional recovery, relapses, memory, and brain imaging outcomes at 1 and 2 years.
What it is studying. The study is testing how clinical features, laboratory findings, and advanced brain imaging relate to outcomes in anti-LGI1 encephalitis—including seizure control, relapse (recurrence), functional recovery, memory performance, and brain volume changes.
What the researchers hope to learn. To describe seizure outcomes and associated factors; to measure clinical severity and recovery using scales such as the modified Rankin Scale and a clinical assessment scale for autoimmune encephalitis; to measure incidence of relapse; to assess memory tests and changes in brain volumes on MRI.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will be seen at the acute stage and during follow-up and will have blood tests and/or cerebrospinal fluid (CSF) sampling (spinal tap). They will undergo advanced brain imaging (multimodal MRI including functional MRI, diffusion tensor imaging, arterial spin labeling), EEG or continuous video‑EEG, and PET scans, plus standardized neuropsychological memory testing. Follow-up assessments include clinical scales and outcome measures at about 1 year and 2 years to record seizures, recurrence, memory, and brain-volume measures.
How the study is structured. A prospective observational cohort study. Participants are assessed during the acute stage and followed over time with repeated exams and tests (blood and/or cerebrospinal fluid testing, multimodal MRI including functional MRI and diffusion imaging, EEG/VEEG, PET, and neuropsychological testing). Outcomes are measured at 1 year and 2 years. No experimental treatment is assigned.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune encephalitis
Important dates
- Study start
- May 18, 2022
- Primary completion
- Dec 31, 2027 (estimated)
- Study completion
- Dec 31, 2032 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Aug 27, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Shen Chun-Hong
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Mei-Ping Ding 📞 +86 0571 87783872 ✉ dmp-neurology@zju.edu.cn
Participating sites (1)
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
Hangzhou, Zhejiang · China
- Chun-Hong Shen · +86 0571 87783872 · shen_neurology@zju.edu.cn
Terms used on this page · explanations by MedicalUpdates.ai
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- magnetic resonance imaging
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- positron emission tomography
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials