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NCT Number: NCT06388161

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

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.

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Key information

Age range

14 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Chun-Hong Shen

CONTACT

[email protected]

+86 0571 87783872

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Detectable serum neural autoantibodies

    Time frame: at baseline

    such as NMDAR、AMPAR1、AMPAR2、LGI1、lg LON5、DPPX、GAD65、mGluR5、MOG

  2. Neuronal surface antibodies-mediated autoimmune- encephalitis

    Time frame: at baseline

    diagnosed according to the 2016 diagnostic criteria

Secondary outcomes

  1. The proportion of seizure freedom

    Time frame: through study completion, an average of 1 year

    We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition

  2. The proportion of drug-resistent epilepsy

    Time frame: through study completion, an average of 1 year

    We defined drug-resistent epilepsy according to the International League Against Epilepsy (ILAE) definition

  3. Clinical severity and recovery

    Time frame: through study completion, an average of 1 year

    modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Hong Shen

CONTACT

[email protected]

+86 0571 87783872

Sponsors and collaborators

Lead sponsor

Shen Chun-Hong

Other

Registry information

Official study title

Neural Autoantibody Prevalence in Patients With New-onset Focal Seizures of Unknown Etiology and a Predictive Scoring Scale

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Apr 29, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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