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RNS® System Epilepsy Post-Approval Study

NCT02403843 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 345

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • NeuroPace

    lead INDUSTRY

Principal Investigators

  • Martha J Morrell, MD · NeuroPace, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2023-12-31
Completion
2026-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02403843 on ClinicalTrials.gov