Not yet recruiting NCT06918457
A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI EEG analysis system.
- Who it may be relevant to
- Registry conditions: Pediatric Epilepsy. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.
Interventions
- Diagnostic test AI 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
Primary outcome measures
- 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]
Secondary outcome measures (1)
- To evaluate the diagnostic efficiency of clinicians at two-stage [Time frame: Immediately after the end of EEG interpretation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06918457 · 2024-03-278-K01