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

NCT06388161 | Recruiting

• 1 other identifier: Yan2022-0336
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Encephalitis Autoimmune

Outcome Measures

Primary Outcomes (2)

• Detectable serum neural autoantibodies

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

  at baseline

• Neuronal surface antibodies-mediated autoimmune- encephalitis

  diagnosed according to the 2016 diagnostic criteria

  at baseline

Secondary Outcomes (3)

• The proportion of seizure freedom

  through study completion, an average of 1 year

• The proportion of drug-resistent epilepsy

  through study completion, an average of 1 year

• Clinical severity and recovery

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have new-onset focal seizure with unknown etiology; and focal seizure is considered according to the seizure seiology, electroencephalography findings and/or other relevant information.

You may qualify if:

• 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

You may not qualify if:

• Patients have other etiology of seizures, such as structure, infection, genetics and metabolism.
• Written informed consent are not obtained
• Loss of follow-up

Sponsors & Collaborators

• Shen Chun-Hong: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and cerebrospinal fluid samples will be stored to test antibodies, cytokines, and other relevant molecules. And patients have the right to destroy them at any time.

MeSH Terms

Conditions

Epilepsy; Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chunhong Shen

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hong Shen

CONTACT

+86 0571 87783872; shen_neurology@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Senior Doctor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 29, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)