Epilepsy Clinical Trial
Official title:
Neural Autoantibody Prevalence in Patients With New-onset Focal Seizures of Unknown Etiology and a Predictive Scoring Scale
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 | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Ningbo Medical Center Lihuili Hospital, Shaoxing People's Hospital, Sir Run Run Shaw Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detectable serum neural autoantibodies | such as NMDAR?AMPAR1?AMPAR2?LGI1?lg LON5?DPPX?GAD65?mGluR5?MOG | at baseline | |
Primary | Neuronal surface antibodies-mediated autoimmune- encephalitis | diagnosed according to the 2016 diagnostic criteria | at baseline | |
Secondary | The proportion of seizure freedom | We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition | through study completion, an average of 1 year | |
Secondary | The proportion of drug-resistent epilepsy | We defined drug-resistent epilepsy according to the International League Against Epilepsy (ILAE) definition | through study completion, an average of 1 year | |
Secondary | Clinical severity and recovery | modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome | through study completion, an average of 1 year |
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