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A clinical trial with a self-controlled, multicenter, pediatric EEG intelligent analysis system to assist in diagnosis

A clinical trial with a self-controlled, multicenter, pediatric EEG intelligent analysis system to assist in diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098269
Enrollment
Unknown
Registered
2025-03-05
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric epilepsy

Interventions

Gold Standard:The physician's diagnosis in conjunction with an EEG
Index test:Children's EEG Intelligent Analysis System

Sponsors

Kunming Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Physician inclusion criteria (1) EEG data interpretation experience: Senior experienced physicians: physician with 10 years or more experience in EEG data interpretation and who have participated in at least 1,000 pediatric EEG epilepsy diagnoses. 2.EEG data collection personnel standards: EEG collectors from multi-center hospitals are required to receive unified training or further training from the team leader unit and pass professional assessment to ensure the standardization of operation and consistency of data quality of all participating physicians. 3. Data inclusion criteria (1) Target population: children aged between 1 and 18 years old with suspected epilepsy who need EEG examination; (2) Data collection requirements: all EEG data are collected in strict accordance with standardized procedures,Refer to the basic technical standards for clinical EEG in guideline 1 and the basic technical standards for electroencephalogram in children in guideline 3 (see CAAE-Clinical EEG Technical Operation Guide, http://www.caae.org.cn/Public/Uploads/20220118/video/61e6242d78ca7.pdf for details) to ensure that the collected data is clear and complete, which is suitable for follow-up system analysis and research needs.

Exclusion criteria

Exclusion criteria: Data exclusion criteria (1) Influence of clinical status: During EEG acquisition, the child has other serious neurological diseases and psychiatric diseases, and the use of drugs that affect EEG data within 3 weeks, such as sedatives and anti-epileptic drugs, is excluded. (2) Substandard data quality: data lack of key records, electrode connection discontinuity, insufficient recording time, or the presence of serious artifacts, etc., resulting in data that do not have the basic quality of EEG data for analysis and diagnosis will be excluded. (3) Incomplete or missing data; (4) Equipment or Operational Abnormalities: Data for which EEG monitoring has not been performed continuously due to equipment failure or technical operational error will be excluded.

Design outcomes

Primary

MeasureTime frame
Diagnostic outcome ("Normal" or "Abnormal");Abnormal waveform type, number and brain discharge site;Accuracy of recognition of absence epilepsy and infantile spasms;Abnormal waveform detection rate, false detection rate, and classification accuracy with and without AI assistance;

Secondary

MeasureTime frame
Diagnostic time;Diagnostic recommendations based on feature waveforms;

Countries

China

Contacts

Public ContactXiaomei Liu

Kunming Children's Hospital

1043443230@qq.com+86 63309016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026