Charles Sternberg, Associate Editor05.06.22
NeuroPace Inc. a medical technology company dedicated to transforming the lives of people suffering from epilepsy, has announced that the first patient was treated in the RESPONSE clinical trial, which will evaluate 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 and follow-up appointments will be conducted at Boston Children’s Health Physicians in New York/Connecticut.
“More than 1 million people are living with drug-resistant epilepsy,” said Steven Wolf, M.D., and Patricia McGoldrick, N.P., Pediatric Epilepsy at Boston Children’s Health Physicians. “The RNS System has demonstrated unprecedented seizure reduction and improved quality of life in adults with drug-resistant focal epilepsy. Through this clinical study, I am looking forward to evaluating the RNS System in an expanded population of adolescent patients who have uncontrolled focal seizures, despite taking medications.”
The RNS System is the only FDA-approved brain-responsive neuromodulation system that delivers personalized, targeted treatment at the seizure source. Unlike 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, M.D., principal investigator of the study and chief medical officer of 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.”
References:
1. U.S. Centers for Disease Control
2. Chen, et al., JAMA Neurology, 2018
The procedure took place at Westchester Medical Center in New York and follow-up appointments will be conducted at Boston Children’s Health Physicians in New York/Connecticut.
Treating Patients with Drug-Resistant Epilepsy
Epilepsy affects 3.4 million people in the U.S., with onset often occurring during the teenage years.1 While antiepileptic drugs are considered first line treatment and are effective at controlling seizures in a large portion of the epilepsy population, approximately one third of epilepsy patients are considered drug resistant because they do not achieve complete seizure control or cannot tolerate the side effects of these drugs.2“More than 1 million people are living with drug-resistant epilepsy,” said Steven Wolf, M.D., and Patricia McGoldrick, N.P., Pediatric Epilepsy at Boston Children’s Health Physicians. “The RNS System has demonstrated unprecedented seizure reduction and improved quality of life in adults with drug-resistant focal epilepsy. Through this clinical study, I am looking forward to evaluating the RNS System in an expanded population of adolescent patients who have uncontrolled focal seizures, despite taking medications.”
About the RESPONSE Study
The RESPONSE Study 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.The RNS System is the only FDA-approved brain-responsive neuromodulation system that delivers personalized, targeted treatment at the seizure source. Unlike 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, M.D., principal investigator of the study and chief medical officer of 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.”
References:
1. U.S. Centers for Disease Control
2. Chen, et al., JAMA Neurology, 2018
