Epilepsy, a prevalent neurological condition, impacts a diverse population with recurring seizures and associated neurobiological, cognitive, psychological, and social consequences. Despite advancements, approximately 30% of epilepsy patients exhibit a poor response to available antiepileptic drugs (AEDs), resulting in refractory epilepsy. Predictors for refractoriness remain unclear due to diverse study variables. Metabolomics, exploring metabolic changes, emerges as a potential diagnostic tool.

This study, conducted at the Department of Neurology, Guwahati Neurological Research Centre (GNRC) Institute of Medical Sciences, North Guwahati, spans three years and employs cross-sectional observational and case-control designs. Ethical approval is obtained from the GNRC Institutional Ethical Committee. The study’s comprehensive design aims to contribute valuable insights into epilepsy patterns, risk factors, and potential biomarkers.

For the primary outcome, a cross-sectional study including a total of 1000 patients will be recruited to evaluate epilepsy patterns, considering demographics, disease status, and the history of AED use. For the secondary objective, the case-control study design will be employed to identify the risk factors of refractory epilepsy in comparison with the drug-responsive epilepsy group.  Further, a case-control study with non-randomized sampling will be utilized to identify the untargeted metabolomic biomarkers in four groups: refractory epilepsy, drug-responsive epilepsy, newly diagnosed epilepsy, and healthy controls. Biofluid samples will undergo processing, and metabolomic analysis will be conducted using pre-defined techniques. Patients/caregivers who are unwilling to provide written consent will be excluded from the study. Statistical analysis will be applied as per the datasets.