Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-100
SponsorShen Chun-Hong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients have other etiology of seizures, such as structure, infection, genetics and metabolism.
Written informed consent are not obtained
Loss of follow-up
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Detectable serum neural autoantibodies
such as NMDAR、AMPAR1、AMPAR2、LGI1、lg LON5、DPPX、GAD65、mGluR5、MOG
Time frame
at baseline2
Neuronal surface antibodies-mediated autoimmune- encephalitis
diagnosed according to the 2016 diagnostic criteria
Time frame
at baselineSecondary outcomes
1
The proportion of seizure freedom
We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition
Time frame
through study completion, an average of 1 year2
The proportion of drug-resistent epilepsy
We defined drug-resistent epilepsy according to the International League Against Epilepsy (ILAE) definition
Time frame
through study completion, an average of 1 year3
Clinical severity and recovery
modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shen Chun-Hong
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor institution
Source ClinicalTrials.gov