What is the purpose of the RNS® System Pivotal Clinical Investigation?
NeuroPace, Inc. is sponsoring an investigational device study of the RNS System, the company’s responsive brain stimulation system for treating refractory epilepsy. The RNS System Pivotal Clinical Investigation is a randomized, double-blind, sham stimulation controlled investigation being conducted at approximately 28 sites throughout the United States. The purpose of the RNS System Pivotal Clinical Investigation is to assess the safety and to demonstrate that the RNS System is effective as an add-on (adjunctive) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures (those that start from one or two areas of the brain) that are refractory (resistant or hard to treat) to two or more antiepileptic medications. Participants in the trial will continue to receive their epilepsy medications. What is the RNS System? The RNS is designed to detect abnormal electrical activity in the brain and to deliver small amounts of electrical stim
