NCT06388161Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 16 Apr 2024
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shen Chun-Hong
- Diseases
- Epilepsy
- NCT number
- NCT06388161
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Aug 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients have other etiology of seizures, such as structure, infection, genetics and metabolism.
Other
- Written informed consent are not obtained
- Loss of follow-up
Who the study is looking for
- 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
Age in the registry: 14 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.