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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06918457
Enrollment
1000
Registered
2025-04-09
Start date
2025-06-03
Completion date
2026-07-01
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Epilepsy

Brief summary

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

Interventions

DIAGNOSTIC_TESTAI EEG analysis system

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

Sponsors

Kunming Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the coincidence rate between doctors' independent diagnosis and the diagnosis recommended by the AI system.Within 48 hours after the completion of EEG monitoringThe 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

MeasureTime frameDescription
To evaluate the diagnostic efficiency of clinicians at two-stageImmediately after the end of EEG interpretationThe time taken by physicians to interpret EEG independently and with the aid of AI was measured.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026