Safety of Intracranial Neuromodulation in Drug-Resistant Pediatric and Adult Epilepsy

BACKGROUND AND OBJECTIVES: Intracranial neuromodulation is an established therapy for drug-resistant epilepsy (DRE) in adults. Improving seizure outcomes and expanding its application to pediatric patients remain priorities. Off-label use of 2-lead and 4-lead devices targeting multiple network nodes, combined with varied stimulation parameters, has emerged in pursuit of better outcomes. Although early findings are promising, the safety of these approaches remains underexplored. This study evaluates adverse event (AE) rates associated with different intracranial neuromodulation devices from a single center. METHODS: This retrospective study from the Mayo Clinic (Rochester, MN) included patients with DRE who underwent intracranial neuromodulation between August 2004 and December 2024. Demographic data, epilepsy characteristics, treatment indications, procedural details, and AEs were extracted from medical records. AEs are undesirable events associated with implantation and use of the device, regardless of causation. Serious AEs were life threatening or resulted in hospitalization, persistent or significant disability, or death. Patients were classified as children (