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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorKunming Children's Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age < 18 years old

Children with suspected epilepsy

Disqualifiers

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

Trial population

children aged \< 18 years old with suspected epilepsy who need EEG examination

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Within 48 hours after the completion of EEG monitoring

Secondary outcomes

1

To evaluate the diagnostic efficiency of clinicians at two-stage

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

Time frame
Immediately after the end of EEG interpretation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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