Identifying neural autoantibodies in patients with new-onset focal seizures
Neural Autoantibody Prevalence in Patients With New-onset Focal Seizures of Unknown Etiology and a Predictive Scoring Scale
This study is trying to find out how common certain antibodies are in people who have recently started having focal seizures that doctors can't explain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years to 100 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06388161 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the prevalence of neural autoantibodies in patients experiencing new-onset focal seizures of unknown origin. It involves a multicenter approach where clinical data, including demographics and seizure characteristics, are collected from patients diagnosed with focal epilepsy within the last year. The study will utilize various scoring systems to determine which patients should undergo autoantibody testing, thereby improving the specificity and cost-effectiveness of the testing process. Additionally, the study will assess cognitive and emotional health using standardized scales.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with new-onset focal epileptic seizures occurring within the past 12 months without obvious signs of autoimmune encephalitis.
Not a fit: Patients with seizures due to other identifiable etiologies, such as structural causes, infections, or genetic factors, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and treatment of autoimmune encephalitis in patients with focal seizures, potentially improving clinical outcomes.
How similar studies have performed: Other studies have shown promise in identifying neural autoantibodies in similar patient populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Chunhong Shen — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Chun-Hong Shen
- Email: shen_neurology@zju.edu.cn
- Phone: +86 0571 87783872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.