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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04516590
• Other study ID #: XijingH Deng Yanchun-1
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor

Collaborator

Xijing Hospital

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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