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Status unknownNCT04516590Updated Aug 18, 2020

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

An observational study in Epilepsy, sponsored by Xijing Hospital. Status unknown. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Xijing Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
16 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Epilepsy

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Keywords

  • epilepsy
  • autoimmune antibody
  • diagnose
03

In context

Epilepsy

1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 130 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients with newly onset or chronic epilepsy

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at six months after the patients being enrolled

  2. 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.

    Time frame: at six months after the patients being enrolled

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04516590
Lead sponsor
Xijing Hospital
Collaborators
General Hospital of Ningxia Medical University, LanZhou University, First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, First Affiliated Hospital of Zhejiang University, Wulumuqi General Hospital of Lanzhou Military Command, Xuanwu Hospital, Beijing, Xiangya Hospital of Central South University, West China Hospital, Affiliated Hospital of Qinghai University
Responsible party
Sponsor
First posted
Aug 18, 2020
Start date
Aug 2020 (estimated)
Primary completion
Sep 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Aug 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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