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

NCT ID: NCT06918457

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-03

Study Completion Date

2026-07-01

Brief Summary

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

Detailed Description

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Conditions

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Pediatric Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kunming Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaomei Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2024-03-278-K01

Identifier Type: -

Identifier Source: org_study_id

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