Pediatric EpilepsyNCT06918457
A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis
An observational study of Pediatric Epilepsy, run by Kunming Children's Hospital.
Trial summary
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Epilepsy
- What is being tested?
- AI EEG analysis system
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children aged < 18 years old with suspected epilepsy who need EEG examination
Who may be able to join
- Age < 18 years old
- Children with suspected epilepsy
Who cannot join
- 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
About this study
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.
- Conditions
- Pediatric Epilepsy
- Being tested
- AI EEG analysis system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI EEG analysis systemDiagnostic test
The first stage, physicians independently diagnose pediatric epilepsy with EEG; the second stage, Artificial intelligence EEG analysis system assisted physicians to diagnose pediatric epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the coincidence rate between doctors' independent diagnosis and the diagnosis recommended by the AI system.
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.
Measured: Within 48 hours after the completion of EEG monitoring
Secondary outcomes (1)
To evaluate the diagnostic efficiency of clinicians at two-stage
The time taken by physicians to interpret EEG independently and with the aid of AI was measured.
Measured: Immediately after the end of EEG interpretation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomei Liu, Kunming Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918457
- Sponsor's protocol ID
- 2024-03-278-K01
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial With a Self-controlled, Multicenter, Pediatric EEG Intelligent Analysis System to Assist in Diagnosis
- ClinicalTrials.gov ID
- NCT06918457
- Acronym / sponsor ID
- 2024-03-278-K01
- Conditions
- Pediatric Epilepsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kunming Children's HospitalUniversity, hospital or other
- Study start
- 3 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A diagnostic accuracy study on Artificial intelligence EEG analysis system assisted doctors to diagnose pediatric epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children aged < 18 years old with suspected epilepsy who need EEG examination
Key inclusion criteria (2 listed)
- Age < 18 years old
- Children with suspected epilepsy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI EEG analysis systemThe first stage, physicians independently diagnose pediatric epilepsy with EEG; the second stage, Artificial intelligence EEG analysis system assisted physicians to diagnose pediatric epilepsy | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
To evaluate the diagnostic efficiency of clinicians at two-stage
Time frame: Immediately after the end of EEG interpretation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Epilepsy, run by Kunming Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.