NeuroPace has announced that the first patient was recently treated in the RESPONSE clinical trial, which is evaluating the safety and effectiveness of the RNS system in adolescent patients with drug-resistant focal epilepsy. The procedure took place at Westchester Medical Center in New York, USA.
“More than one million people are living with drug-resistant epilepsy,” said Steven Wolf and Patricia McGoldrick (Boston Children’s Health Physicians, New York, USA). “The RNS system has demonstrated unprecedented seizure reduction and improved quality of life in adults with drug-resistant focal epilepsy. Through this clinical study, we are looking forward to evaluating the RNS system in an expanded population of adolescent patients who have uncontrolled focal seizures, despite taking medications.”
The RESPONSE trial is a prospective, open label, single-arm, pivotal study designed to demonstrate that the RNS system is safe and effective as an adjunctive therapy in individuals aged 12 through 17 years with medically refractory, partial-onset epilepsy.
According to NeuroPace, the RNS system is the only US Food and Drug Administration (FDA)-approved brain-responsive neuromodulation system that delivers personalised, targeted treatment at the seizure source. And, unlike many other neuromodulation devices, the RNS system is a closed-loop technology that monitors and responds to a patient’s unique brain patterns to deliver therapy in real-time, typically before clinical symptoms occur.
“The RESPONSE study is an exciting opportunity to evaluate the safety and effectiveness of the RNS system in a younger population aged 12 through 17, when seizures can profoundly impact school, social development, and self-esteem, as well as expose the teen to all of the risks of seizures themselves,” said Martha Morrell, principal investigator of the study and chief medical officer at NeuroPace. “Our recent announcement of nearly 11 years of battery life for the RNS system is especially beneficial to younger patients—fewer replacement procedures translates into lower health risk and lower cost for patients.”