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

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

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Anticipated): 130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with newly onset or chronic epilepsy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
autoimmune antigen negative; treated with anti-epilepsy drugs
autoimmune antigen positive; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of the seizure frequency	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	at six months after the patients being enrolled
change of the autoimmune antigen	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.	at six months after the patients being enrolled

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Xiangya Hospital of Central South University; LanZhou University; First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; Xuanwu Hospital, Beijing; First Affiliated Hospital of Zhejiang University; Henan Provincial People's Hospital; General Hospital of Ningxia Medical University; The Affiliated Hospital of Inner Mongolia Medical University; Affiliated Hospital of Qinghai University; Wulumuqi General Hospital of Lanzhou Military Command

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: epilepsy; diagnose; autoimmune antibody
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: XijingH Deng Yanchun-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No