Safety of responsive neurostimulation in pediatric and young adult patients with drug-resistant epilepsy: a systematic review and meta-analysis

OBJECTIVE Responsive neurostimulation (RNS) is increasingly being used for pediatric drug-resistant epilepsy (DRE), but the safety of the procedure in children remains unclear. The authors systematically reviewed published clinical outcomes in pediatric RNS, with an emphasis on complications and other adverse events. METHODS The authors performed a PRISMA-guided systematic review and meta-analysis. PubMed, Embase, Web of Science, and the Cochrane Library were searched from inception through August 12, 2025. They included observational studies reporting outcomes of RNS in patients aged ≤ 21 years at implantation and extractable pediatric data. Two authors independently screened articles and extracted data. The primary outcome was the proportion of patients experiencing at least 1 complication. A sensitivity analysis restricted to extractable patients aged ≤ 18 years was also performed. RESULTS Thirty-five studies met inclusion criteria, representing 358 pediatric patients who underwent RNS implantation. Most studies were case series (62.9%), followed by case reports (25.7%) and cohort studies (11.4%); all were conducted in the United States. The mean patient age at implantation was 14.8 years, and the mean follow-up was 20.3 months among studies reporting follow-up. Overall, 38 patients experienced at least 1 complication. The most frequently reported complications were infection (3.4%), transient neurological deficits (3.1%), return to the operating room (2.2%), and explantation (2.0%). Less common events included stimulation-related side effects (1.4%), CSF-related complications (1.1%), and wound dehiscence and device malfunction (0.6% each). Random-effects meta-analysis demonstrated a pooled overall complication proportion of 10.3% (95% CI 7.0%–14.9%; I 2 = 0.0%). In the ≤ 18-year sensitivity analysis, 31 studies comprising 203 patients were included, with a pooled complication proportion of 8% (95% CI 4%–16%). CONCLUSIONS Published pediatric RNS experience suggests that complications are comparable to rates reported for similar procedures and are most often transient neurological symptoms, reoperation, or infection. However, the evidence base is largely limited to small observational reports with heterogeneous outcome definitions and high risk of bias. Higher-quality multicenter prospective studies with standardized reporting and longer follow-up are needed to better define safety and effectiveness of RNS in pediatric DRE. Systematic review registration no.: CRD420261339088 ( https://www.crd.york.ac.uk/prospero/ )