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

NCT04516590 | Unknown

• 1 other identifier: XijingH Deng Yanchun-1
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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

Conditions

Epilepsy

Keywords

epilepsy; autoimmune antibody; diagnose

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with newly onset or chronic epilepsy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Epilepsy; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: August 18, 2020
• Study Start: August 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share