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Recruiting Observational

Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology

NCT06388161 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-08-01
Last updated
2025-08-27

Condition(s) studied

EpilepsyEncephalitis Autoimmune

Study summary

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

Sex
ALL
Min age
14 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Detectable serum neural autoantibodies — at baseline
    such as NMDAR、AMPAR1、AMPAR2、LGI1、lg LON5、DPPX、GAD65、mGluR5、MOG
  • Neuronal surface antibodies-mediated autoimmune- encephalitis — at baseline
    diagnosed according to the 2016 diagnostic criteria

Trial sites (1)

FacilityCityRegionStatus
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06388161 on ClinicalTrials.gov ↗ ← All trials in China