NCT02403843

RNS® System Epilepsy Post-Approval Study

RNS® System Post-Approval Study in Epilepsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 345 (actual)
• Sponsor: NeuroPace · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.

Detailed description

NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS System is the first FDA-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures. The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective observational study. Data regarding safety and efficacy are collected at enrollment and periodically throughout the 5-year study. The study is designed to assess the long-term safety and effectiveness of the RNS System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial 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 (motor partial seizures, complex partial seizures and/or secondarily generalized seizures). Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median percent change in seizure frequency (from pre-implant retrospective data), as well as other safety and effectiveness endpoints.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	RNS System	The RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Timeline

• Start date: 2015-06-01
• Primary completion: 2023-12-01
• Completion: 2026-01-01
• First posted: 2015-03-31
• Last updated: 2026-04-09

Locations

35 sites across 1 country: United States