Safety of responsive neurostimulation in pediatric patients with medically refractory epilepsy

Abstract

OBJECTIVEApproximately 75% of pediatric patients who suffer from epilepsy are successfully treated with antiepileptic drugs, while the disease is drug resistant in the remaining patients, who continue to have seizures. Patients with drug-resistant epilepsy (DRE) may have options to undergo invasive treatment such as resection, laser ablation of the epileptogenic focus, or vagus nerve stimulation. To date, treatment with responsive neurostimulation (RNS) has not been sufficiently studied in the pediatric population because the FDA has not approved the RNS device for patients younger than 18 years of age. Here, the authors sought to investigate the safety of RNS in pediatric patients.METHODSThe authors performed a retrospective single-center study of consecutive patients with DRE who had undergone RNS system implantation from September 2015 to December 2019. Patients were followed up postoperatively to evaluate seizure freedom and complications.RESULTSOf the 27 patients studied, 3 developed infections and were treated with antibiotics. Of these 3 patients, one required partial removal and salvaging of a functioning system, and one required complete removal of the RNS device. No other complications, such as intracranial hemorrhage, stroke, or device malfunction, were seen. The average follow-up period was 22 months. All patients showed improvement in seizure frequency.CONCLUSIONSThe authors demonstrated the safety and efficacy of RNS in pediatric patients, with infections being the main complication.

Responsive Neurostimulation Targeting the Anterior, Centromedian and Pulvinar Thalamic Nuclei and the Detection of Electrographic Seizures in Pediatric and Young Adult Patients

“…While there is currently no FDA approval for RNS treatment in patients under the age of 18, our study corroborates reports of efficacy and safety of RNS in the pediatric population ( Panov et al, 2020 ; Welch et al, 2021 ). None of the patients in the present study experienced any adverse events necessitating either discontinuation of RNS therapy or corrective surgery.…”

“…Ictal activity in neocortical leads preceded thalamic involvement in all patients with combined neocortical and thalamic lead sets, by visual inspection of their ECoG recordings. A Granger causality analysis of ECoG recordings in Lennox-Gastaut Syndrome (LGS) patients found evidence supporting neocortical precedence ( Panov et al, 2020 ; Welch et al, 2021 ), and our own findings appear to corroborate this, as two of our patients with corticothalamic lead sets had a primary epilepsy diagnosis of LGS.…”

Case Report: Responsive Neurostimulation of the Centromedian Thalamic Nucleus for the Detection and Treatment of Seizures in Pediatric Primary Generalized Epilepsy

“…Children with PGE experience considerable burden on their quality of life and often experience cognitive, behavioral, and developmental deficits as a result of uncontrolled epilepsy during this critical period of brain development ( 4 – 7 ). Neocortical RNS implantation has been used successfully for the treatment of pediatric drug-resistant seizures in a few cases ( 42 – 45 ). Together, these provide preliminary evidence that RNS is a viable therapeutic option for patients with drug-resistant epilepsy who are not candidates for resective epilepsy surgery.…”

Centromedian thalamic responsive neurostimulation for Lennox‐Gastaut epilepsy and autism

“…However, the current RNS System is only approved in patients ≥18 years and only approved for treatment of ≤2 seizure foci. We have used RNS in children (off‐label) 3–5 and adults, and have found no difference in safety or efficacy in our early experience. To reach a dramatically underserved population, children with MR‐negative epilepsy, 6 we have broadened the scope of RNS utilization.…”