NCT04839601

RNS System RESPONSE Study

RNS® System Responsive Stimulation for Adolescents With Epilepsy Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: NeuroPace · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.

Detailed description

NeuroPace is sponsoring the RESPONSE Study with the RNS System in individuals age 12 through 17 with partial (focal) onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures. For the purposes of this study, disabling seizures are defined as motor partial seizures, complex partial seizures, and/or secondarily generalized seizures. The RNS System is currently approved by the FDA for use in patients 18 years and older with hard-to-treat partial-onset seizures. The same device will be used in the RESPONSE Study. The study is a prospective open label single arm pivotal study and participants will be followed for 2 years after placement of the RNS System. The study will enroll a maximum of 200 subjects within the United States to ensure that at least 150 subjects are implanted with the RNS System. The study design includes one interim analysis which will occur after the 75th implanted patient reaches 12 months post-implant. If the study achieves its primary safety and effectiveness endpoint goals at the interim analysis, the study will be considered successful and enrollment will be stopped. If the interim analysis does not achieve the primary safety and effectiveness endpoint goals, the study will continue enrolling up to the maximum of 200 patients. A final analysis will be conducted after the 150th implanted patient reaches 12 months post-implant.

Conditions

• Epilepsy
• Partial Seizure
• Neurostimulator; Complications
• Drug Resistant Epilepsy
• Focal Epilepsy

Interventions

Type	Name	Description
DEVICE	RNS System	The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.

Timeline

• Start date: 2021-10-27
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-04-09
• Last updated: 2025-05-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study