BALTIMORE — Responsive stimulation via the RNS® System has no adverse effects on adult patients with medically intractable partial onset seizures, according to study findings presented at the 2014 American Neurological Association Annual Meeting.
The RNS® System (NeuroPace) is an implantable and external product that detects and responds to abnormal electrical activity in the brain by emitting electrical stimulation that normalizes brain activity prior to epileptic seizure.
Martha J. Morrell, MD, of the Stanford University School of Medicine, and colleagues evaluated the impact on quality of life and mood in patients that participated in a two-year, randomized, double-blind controlled trial of the RNS® System as treatment for intractable partial epilepsy.
The Quality of Life in Epilepsy Inventory-89 (QOLIE-89) and mood inventories including the Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), and Profile of Mood States (POMS) were administered at baseline, after a 12-week blinded period, and one and two years after implant. A total of 191 participants were randomly assigned to received responsive stimulation or sham placebo treatment during the blinded period.
The results showed statistically significant improvement from baseline (P<0.05) in QOLIE-89 scores in both groups at the end of the blinded period and one and two years after, and no adverse change in mood was observed. The number of patients categorized as having depression or reporting suicidality remained stable throughout the study.
Responsive stimulation via the RNS® System in adults with medically intractable partial onset seizures resulted in steady improvement in QOL scores and no decline in mood, and therefore is a safe and effective treatment, the researchers concluded.
- Kapur R et al. Abstract #S213 “Quality of Life (QOL) and Mood in Adults with Medically Intractable Partial Onset Seizures Treated with Responsive Cortical Stimulation” Presented at: American Neurological Association 2014 Annual Meeting. Oct 12-14, 2014; Baltimore.
Disclosures: This study received funding from NeuroPace, Inc., and several researchers are either employees of NeuroPace, Inc., or served as paid consultants for the company.