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

April 6, 2025 updated by: Xiaomei Liu, Kunming Children's Hospital
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 48 hours after the completion of EEG monitoring

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the diagnostic efficiency of clinicians at two-stage
Time Frame: Immediately after the end of EEG interpretation
The time taken by physicians to interpret EEG independently and with the aid of AI was measured.
Immediately after the end of EEG interpretation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kunming Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 3, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-03-278-K01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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