The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy

• Conditions: Epilepsy

• Registration Number: NCT04516590
• Lead Sponsor: Xijing Hospital

Brief Summary

multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice

Detailed Description

multi-centrally recruit patients with newly onset or chronic epilepsy and hoping to find whether there exist an autoimmune cause. whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom. At 3 and 6 months later, all patients will be followed-up, and the positive autoimmune antibody will be redetected. the clinical manifest, clinical data, medication and treatment outcome will be recorded and analyzed, to study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy

Study Timeline

• Study First Submitted: 2020-06-30
• Status Verified: 2020-08
• Study Start: 2020-08
• Study First Submitted QC: 2020-08-16
• Last Update Submitted: 2020-08-16
• Study First Posted: 2020-08-18
• Last Update Posted: 2020-08-18
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients diagnosed with epilepsy according to the diagnostic criteria of International League Against Epilepsy (ILAE) 2017
• Age from 16 to 70 years old
• The etiology of patients with epilepsy is unknown
• The patient or guardian signs an informed consent and can cooperate with the inspection and follow-up for six months

Exclusion Criteria

• Patients with hereditary, infectious, and metabolic epilepsy
• The investigation and follow-up cannot be completed due to vision, hearing, language expression, disturbance of consciousness, and impaired understanding, and the guardian cannot replace the completed
• Patients with other progressive or systemic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of the seizure frequency	at six months after the patients being enrolled	Seizure frequency are described as no seizures, less than one per month, monthly, weekly, and daily. the change of seizure frequency include 'increased', 'decreased', and 'no change' compared to the frequency before they were enrolled
change of the autoimmune antigen	at six months after the patients being enrolled	autoimmune antigen in the serum of patients was described as positive and negative. the change of the autoimmune antigen include 'turn negative' and 'still positive' compared to the first detection.