Epilepsy, Epilepsy (Treatment Refractory)
Conditions
Brief summary
This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy.
Detailed description
Epilepsy is one of the most common neurological disorders in childhood. Approximately one-third of pediatric patients eventually develop drug-resistant epilepsy despite appropriate antiseizure medication treatment. Early identification of children at high risk of drug resistance may facilitate timely referral for advanced therapies including epilepsy surgery, ketogenic diet, or neuromodulation. This prospective cohort study aims to identify independent predictors of drug-resistant epilepsy in children treated at Children's Hospital 1, Ho Chi Minh City, Vietnam. Clinical characteristics, electroencephalography findings, neuroimaging, genetic testing, metabolic investigations, treatment response, and developmental outcomes will be prospectively collected. Cox proportional hazards regression will be used to identify independent predictors of drug resistance. Machine learning models including logistic regression and random forest will subsequently be developed and internally validated to predict drug-resistant epilepsy.
Interventions
OTHERNo Intervention: Observational Cohort
Participants will receive standard clinical care as determined by their treating physicians. No intervention is assigned by the study protocol. The study is observational and does not influence treatment decisions.
Sponsors
Pham Ngoc Thach University of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children younger than 16 years, including neonates. * Diagnosed with epilepsy according to International League Against Epilepsy criteria. * Receiving treatment or follow-up at Children's Hospital 1. * Parent or legal guardian provides informed consent. * Expected follow-up of at least 12 months.
Exclusion criteria
* Poor treatment adherence. * Insufficient baseline data. * Lost to follow-up. * Psychogenic nonepileptic seizures. * Severe systemic illness interfering with antiseizure medication. * Acute symptomatic seizures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Drug-Resistant Epilepsy | Minimum 12 months after initiation of antiseizure medication | Development of drug-resistant epilepsy according to the International League Against Epilepsy definition after failure of two appropriately selected and tolerated antiseizure medications. |
Secondary
| Measure | Time frame |
|---|---|
| Time to drug-resistant epilepsy | Up to 36 months |
Countries
Vietnam
Outcome results
None listed