Autoimmune EncephalitisNCT07722286
Relapse and Functional Outcomes in Anti-LGI1 Encephalitis
An observational study of Autoimmune Encephalitis and LGI1 Encephalitis, run by Shen Chun-Hong at 1 site in China.
Trial summary
This study focuses on a rare brain disease called anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. In this condition, the body's immune system mistakenly attacks a protein in the brain, which can cause problems with memory, thinking, behavior, and seizures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Encephalitis, LGI1 Encephalitis, Limbic Encephalitis
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients at five tertiary medical centers from four cities in Eastern China (Second Affiliated Hospital of Zhejiang University School of Medicine, Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Shaoxing People's Hospital, Ningbo Medical Center Lihuili Hospital, and Huzhou Third People's Hospital)
Who may be able to join
- Characteristic presentations of anti-LGI1 encephalitis;
- LGI1-immunoglobulin G (IgG) positivity in serum and/or cerebrospinal fluid (CSF) by fixed cell-based assay (Euroimmun, Lübeck, Germany)
- follow-up ≥ 18 months after initial immunotherapies
- exclusion of alternative diagnoses
Who cannot join
- presence of coexisting neural autoantibodies
- history of central nervous system (CNS) infections, severe neurological or primary psychiatric disorders
- no prior use or lack of first-line immunotherapy
- insufficient follow-up data
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
Official title: Relapse and Functional Outcomes in Anti-LGI1 Encephalitis: A Multicenter Study
This study focuses on a rare brain disease called anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. In this condition, the body's immune system mistakenly attacks a protein in the brain, which can cause problems with memory, thinking, behavior, and seizures. While most patients get better with initial treatments, some continue to have long-term symptoms or experience a return of the disease (called a "relapse") months or years later. The goal of this study is to understand how often these relapses and long-term problems happen and to identify which patients are most at risk.
The investigators will look back at the medical records of patients diagnosed with anti-LGI1 encephalitis at five major hospitals in Eastern China. The information about their symptoms, the treatments they received and how they recovered over time are obtained. Then, the investigators will analyze this information to find out what factors are linked to having a relapse or a poor long-term recovery.
By understanding the risks for relapse and poor outcomes, doctors can better identify which patients need closer monitoring and more long-term treatment strategies. The results of this study will help create better guidelines for managing patients with this disease after their initial recovery, aiming to improve their quality of life in the long run.
Read the detailed description
- Study Background: Anti-LGI1 encephalitis is an autoimmune disorder where the body produces antibodies that attack the brain, leading to symptoms like memory loss, psychiatric issues, and seizures. Initial treatments with immunotherapy (like steroids) are effective for most patients. However, a significant number of patients are left with lasting neurological problems, and some experience a return of the disease (relapse) after a period of improvement. The rates of relapse and poor long-term outcomes reported in previous studies vary widely, and it is not clear which patients are most vulnerable. Furthermore, the best strategy for long-term treatment after the initial phase to prevent relapses is not well-established.
- Study Objectives This study aims to:
- Describe how often patients with anti-LGI1 encephalitis experience a relapse of the disease.
- Assess their long-term functional recovery.
- Identify patient characteristics, symptoms, or treatment factors that may increase the risk of relapse or poor recovery.
- Data Collection Data was gathered from electronic medical records and, when necessary, follow-up phone interviews. The information collected includes:
- Patient Demographics: Age, sex.
- Initial Illness: Symptoms at diagnosis, severity of the disease.
- Test Results: Findings from brain scans (MRI), brain wave tests (EEG), antibody levels and other relevant information.
- Treatments: Primarily types and durations of immunotherapy received (e.g., steroids, intravenous immunoglobulin, and maintenance immunosuppressants).
- Outcome Definitions
- Relapse: The return of new or worsening symptoms after the patient had been stable or improving for at least 3 months.
- Functional Outcome: The patient was largely independent in their daily activities at the last follow-up.
- Keywords
- Anti-LGI1 Encephalitis, Relapse, Seizure recurrence, Risk factor
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Limbic Encephalitis, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
the presence of new or worsening clinical features after at least 3 months of stability or improvement
Measured: Through study completion, with the last follow-up date in January 2026
Secondary outcomes (1)
Functional outcomes
an mRS score at the last follow-up ≤ 2 indicated good outcome, while an mRS score > 2 indicated poor outcome
Measured: Through study completion, with the last follow-up date in January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jan 2015
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shen Chun-Hong
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Shaoxing People's Hospital, Ningbo Medical Center Lihuili Hospital, Huzhou Third People's Hospital
- Responsible party
- Sponsor-investigator, Shen Chun-Hong, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722286
- Sponsor's protocol ID
- 2024-0682
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse and Functional Outcomes in Anti-LGI1 Encephalitis: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07722286
- Acronym / sponsor ID
- 2024-0682
- Keywords
- Anti-LGI1 Encephalitis, Relapse, Seizure recurrence, Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shen Chun-HongUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Shaoxing People's Hospital, Ningbo Medical Center Lihuili Hospital, Huzhou Third People's Hospital
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 23 Jul 2026 (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.
This study focuses on a rare brain disease called anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. In this condition, the body's immune system mistakenly attacks a protein in the brain, which can cause problems with memory, thinking, behavior, and seizures. While most patients get better with initial treatments, some continue to have long-term symptoms or experience a return of the disease (called a "relapse") months or years later. The goal of this study is to understand how often these relapses and long-term problems happen and to identify which patients are most at risk.
The investigators will look back at the medical records of patients diagnosed with anti-LGI1 encephalitis at five major hospitals in Eastern China. The information about their symptoms, the treatments they received and how they recovered over time are obtained. Then, the investigators will analyze this information to find out what factors are linked to having a relapse or a poor long-term recovery.
By understanding the risks for relapse and poor outcomes, doctors can better identify which patients need closer monitoring and more long-term treatment strategies. The results of this study will help create better guidelines for managing patients with this disease after their initial recovery, aiming to improve their quality of life in the long run.
Detailed description
- Study Background: Anti-LGI1 encephalitis is an autoimmune disorder where the body produces antibodies that attack the brain, leading to symptoms like memory loss, psychiatric issues, and seizures. Initial treatments with immunotherapy (like steroids) are effective for most patients. However, a significant number of patients are left with lasting neurological problems, and some experience a return of the disease (relapse) after a period of improvement. The rates of relapse and poor long-term outcomes reported in previous studies vary widely, and it is not clear which patients are most vulnerable. Furthermore, the best strategy for long-term treatment after the initial phase to prevent relapses is not well-established.
- Study Objectives This study aims to:
- Describe how often patients with anti-LGI1 encephalitis experience a relapse of the disease.
- Assess their long-term functional recovery.
- Identify patient characteristics, symptoms, or treatment factors that may increase the risk of relapse or poor recovery.
- Data Collection Data was gathered from electronic medical records and, when necessary, follow-up phone interviews. The information collected includes:
- Patient Demographics: Age, sex.
- Initial Illness: Symptoms at diagnosis, severity of the disease.
- Test Results: Findings from brain scans (MRI), brain wave tests (EEG), antibody levels and other relevant information.
- Treatments: Primarily types and durations of immunotherapy received (e.g., steroids, intravenous immunoglobulin, and maintenance immunosuppressants).
- Outcome Definitions
- Relapse: The return of new or worsening symptoms after the patient had been stable or improving for at least 3 months.
- Functional Outcome: The patient was largely independent in their daily activities at the last follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients at five tertiary medical centers from four cities in Eastern China (Second Affiliated Hospital of Zhejiang University School of Medicine, Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Shaoxing People's Hospital, Ningbo Medical Center Lihuili Hospital, and Huzhou Third People's Hospital)
Key inclusion criteria (4 listed)
- Characteristic presentations of anti-LGI1 encephalitis;
- LGI1-immunoglobulin G (IgG) positivity in serum and/or cerebrospinal fluid (CSF) by fixed cell-based assay (Euroimmun, Lübeck, Germany)
- follow-up ≥ 18 months after initial immunotherapies
- exclusion of alternative diagnoses
Key exclusion criteria (4 listed)
- presence of coexisting neural autoantibodies
- history of central nervous system (CNS) infections, severe neurological or primary psychiatric disorders
- no prior use or lack of first-line immunotherapy
- insufficient follow-up data
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
Relapse
Time frame: Through study completion, with the last follow-up date in January 2026
the presence of new or worsening clinical features after at least 3 months of stability or improvement
1 secondary outcome
Functional outcomes
Time frame: Through study completion, with the last follow-up date in January 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 LGI1 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: Through study completion, with the last follow-up date in January 2026). 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 23 Jul 2026.