1160 Safety Profile of Intracranial Stimulation for Drug-Resistant Epilepsy in Children

INTRODUCTION: Children with drug-resistant epilepsy (DRE) in whom resection or disconnective surgeries are not recommended can still benefit from neurostimulation. Vagus nerve stimulation is FDA-approved for ages = 4, but intracranial stimulators, responsive neurostimulation (RNS) and deep brain stimulation (DBS), are only approved for ages = 18. Studies in adults and early experience in children suggest that intracranial stimulation may be more effective than VNS, but with higher risk. This risk has not been examined in large cohorts. METHODS: This retrospective study examined records of DRE patients who underwent RNS/DBS at Children’s Hospital of Philadelphia from 11/2017–3/2024. DBS electrodes were placed in anterior or centromedian thalamic nuclei. RNS electrodes were placed in seizure foci. RESULTS: 57 patients, age 6–23, underwent intracranial stimulator implantation for DRE, (27 DBS, 30 RNS). Six patients (9.0%) returned to surgery: one surgical site infection requiring explant with successful re-implantation; two experienced traumatic scalp lacerations, one salvaged and another explanted; one underwent wound revision for superficial dehiscence; one underwent explant for multiple sclerosis-related perielectrode inflammation. No patient experienced hemorrhage, hydrocephalus, lead malposition, or long-term stimulation-induced paresthesia, depression, or memory loss. One patient (1.8%) died from sudden unexpected death in epilepsy 28 months post-RNS placement. CONCLUSIONS: This study represents, to the best of our knowledge, the largest single-center series of intracranial stimulation for pediatric DRE. In comparison to established rates of SSI and explant in adults, (12.1%/7.0% in the RNS pivotal trial and 13.3%/8.6% in the DBS SANTE trial), our cohort demonstrated more favorable rates of 1.8%/5.3%. Studies with larger pediatric DRE cohorts are needed with longer follow-up and seizure outcomes to elucidate the risk/benefit balance of intracranial stimulation in children.