ClinicalTrials.gov record NCT06388161
Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology
Neural Autoantibody Prevalence in Patients With New-onset Focal Seizures of Unknown Etiology and a Predictive Scoring Scale
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 looks for neural autoantibodies in people with new-onset focal seizures of unknown cause. It gathers clinical information, cognitive and mood assessments, EEG/MRI when applicable, and blood tests for specific neural antibodies; cerebrospinal fluid testing is performed if serum antibodies are found. The study also aims to develop a scoring system to help decide who should get autoantibody testing.
What it is studying. The study tests whether people with new-onset focal seizures of unknown etiology have detectable neural autoantibodies and whether a predictive scoring scale can be developed to preselect patients for antibody testing. It also collects about one year of outcome data (seizure freedom, drug-resistant epilepsy, and functional status) to relate antibody findings to the clinical course.
What the researchers hope to learn. To measure how often neural autoantibodies occur in new-onset focal seizures of unknown cause; to develop and test a scoring system to identify who should receive antibody testing; and to examine the relationship between antibody status and one-year seizure and functional outcomes.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage. It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients have a diagnosis of new-onset focal epileptic seizure or epilepsy and present with their first seizure within the previous 12 months
- Patients are prospectively recruited from the routine practice of epileptologists in epilepsy centers and epilepsy clinics
- There is no obvious suspicion of autoimmune encephalitis
- Written informed consent and sera are obtained
- Cerebrospinal fluid test must be conducted, when patients have detectable serum autoantibodies
Exclusion criteria
- Patients have other etiology of seizures, such as structure, infection, genetics and metabolism.
- Written informed consent are not obtained
- Loss of follow-up
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
- Focal epileptic seizure or epilepsy is defined according to seizure semiology, electroencephalography findings and/or other relevant information. If applicable, 24 hour video-electroencephalography is performed.
- Clinical information is documented by specially-assigned persons, including patient demographics, age at onset, disease duration, seizure semiology, seizure frequency, clinical manifestations, underlying malignancy, hyponatremia, brain MRI, medications and other diseases.
- The Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Hamilton Depression Scale (HAMA), Hamilton Anxiety Scale (HAMA) and the modified Rankin Scale (mRS) at baseline were assessed and recorded.
- Previous scoring scales, such as antibody prevalence in epilepsy and encephalopathy (APE2) score, antibodies contributing to focal epilepsy signs symptoms (ACES) score and the "Obvious" Indications for Neural Antibody Testing in Epilepsy or Seizures (ONES) checklist are evaluated at baseline.
- Commercial cell-based assay (CBA; EUROIMMUN, Lübeck, Germany) was used to detect serum anti-N-methyl-D-aspartate receptor (anti-NMDAR), anti-α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (anti-AMPAR), anti-γ-aminobutyric acid B receptor (anti-GABABR), anti-leucine-rich glioma-inactivated 1 (anti-LGI1), anti-contactin-associated protein-like 2 (anti-CASPR2), and anti-glutamic acid decarboxylase 65 (anti-GAD65), anti-metabotropic glutamate receptor 5 (mGluR5), anti-dipeptidyl peptidase-like protein 6 (DPPX), anti-myelin oligodendrocyte glycoprotein (MOG) and anti-immunoglobulin-like cell adhesion molecule 5 (IgLON5) antibodies. If serum neural autoantibodies are detected, cerebrospinal fluid should be tested.
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.
At baseline you will have clinical information recorded and brief assessments (cognitive and mood scales, modified Rankin Scale). You will give blood for neural autoantibody testing and may undergo EEG and brain imaging as part of routine care; if blood testing finds neural autoantibodies, a cerebrospinal fluid test (lumbar puncture) is required. The study collects standard clinical data and existing scores (for example APE2, ACES, ONES) and follows your seizure outcomes and disability over about one year. Written informed consent is required.
How the study is structured. A prospective, multicenter observational cohort. Participants are seen at baseline with documentation of seizure history and exams; cognitive and mood scales (MMSE, MoCA, Hamilton scales, modified Rankin Scale) are recorded. EEG (including 24-hour video-EEG if applicable) and brain MRI data are collected from routine care. Blood is tested for specific neural autoantibodies using a commercial cell-based assay; if serum antibodies are detected, cerebrospinal fluid testing is required. Existing antibody-prediction scores (APE2, ACES, ONES) are evaluated at baseline and participants are followed for about one year for seizure and functional outcomes.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Epilepsy; Encephalitis Autoimmune. Does it apply to my diagnosis?
- 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
- Aug 1, 2023
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2030 (estimated)
- Target enrollment
- 300 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.
- Chun-Hong Shen 📞 +86 0571 87783872 ✉ shen_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
- Written informed consent
- 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.
- MRI
- 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.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
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.
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