A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis

A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pediatric Epilepsy

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age < 18 years old
Children with suspected epilepsy

Exclusion criteria

During EEG monitoring, the patients had other serious neurological diseases and mental diseases concurrently
Used medication that affect EEG data within 3 weeks, such as sedatives and anti-epileptic medications
Substandard data quality, such as data lack of key records, electrode connection discontinuity, insufficient recording time, or the presence of serious artifacts
Incomplete or missing data
Equipment or operational abnormalities, data for which EEG monitoring has not been performed continuously

Treatment and study plan

AI EEG analysis system

Diagnostic Test

The first stage, physicians independently diagnose pediatric epilepsy with EEG; the second stage, Artificial intelligence EEG analysis system assisted physicians to diagnose pediatric epilepsy

Primary outcomes

To evaluate the coincidence rate between doctors' independent diagnosis and the diagnosis recommended by the AI system.

Time frame: Within 48 hours after the completion of EEG monitoring

The reference standard is the EGG interpreted by 3 clinicians who had attended the uniformly training program and had more than 5 years of experience in diagnosing epilepsy in children.

Secondary outcomes

To evaluate the diagnostic efficiency of clinicians at two-stage

Time frame: Immediately after the end of EEG interpretation

The time taken by physicians to interpret EEG independently and with the aid of AI was measured.

Sponsors and collaborators

Lead sponsor

Kunming Children's Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 9, 2025
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting