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Enrolling by invitation NCT07448233

Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas

No phase Interventional Epilepsies Remote Management of Epilepsy in Rural Areas

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-enabled WeChat mini-program "Epilepsy Smart Monitoring and Diagnosis System":.
Who it may be relevant to
Registry conditions: Epilepsies, Remote Management of Epilepsy in Rural Areas. Basic parameters: 18 years — 65 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This project, titled "Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas ", is led by the First Affiliated Hospital of Air Force Medical University, with Jiang Wen as the principal investigator. It is a prospective, multicenter, cluster-randomized controlled trial involving 756 patients from eight rural counties in China's northwest region. The study aims to evaluate the effectiveness of an AI-assisted remote healthcare system (via a WeChat mini-program) compared to standard care in reducing seizure frequency and improving self-management skills among adult epilepsy patients. Key components include patient and doctor interfaces for features like AI consultations, medication reminders, and online consultations. The trial runs from December 1, 2025, to November 30, 2027, with primary outcomes measured at 12 months and secondary outcomes assessing medication adherence, quality of life, and safety.

Interventions

  • Device AI-enabled WeChat mini-program "Epilepsy Smart Monitoring and Diagnosis System":
    Patient Module: Real-time monitoring, medication reminders, AI consultations, seizure logging, educational resources. Physician Module: AI-assisted diagnostics, online consultations, data analytics dashboard.

Primary outcome measures

  • Seizure change [Time frame: 12 months]
  • Epilepsy Self Management Scale Score [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Meets ILAE 2017 diagnostic criteria for epilepsy.
  • ≥1 bilateral tonic-clonic seizure in the past 12 months.
  • Aged 18-65 years.
  • Access to a smartphone patient/caregiver.
  • Written informed consent.

Exclusion criteria

  • Pregnancy, lactation, or planned pregnancy.
  • Seizures with identifiable triggers e.g., alcohol withdrawal.
  • Allergy to phenobarbital/sodium valproate.
  • Severe comorbidities e.g., organ dysfunction, malignancy, psychiatric disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Health services research

Study locations

China · 1 center
  • Department of Neurology, Xijing Hospital, Air Force Medical University — Xi'an

Identifiers

NCT: NCT07448233 · XJLL-KY-20252555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗