NCT06918457Not yet recruitingNot Applicable
A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis
Kunming Children's Hospital0 sites1,000 target enrollmentStarted: June 3, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,000
- Primary Endpoint
- To evaluate the coincidence rate between doctors' independent diagnosis and the diagnosis recommended by the AI system.
Study Overview
Brief Summary
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Outcomes
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(Immediately after the end of EEG interpretation)
Investigators
Xiaomei Liu
Professor
Kunming Children's Hospital
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