NAUTILUS Study | RNS® System Responsive Thalamic Stimulation for IGE

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Notification

The RNS® System was granted a Breakthrough Device Designation by the FDA for assessment in Idiopathic Generalized Epilepsy

Learn more
THE RNS® System Nautilus Study

Committed to Life-Changing Outcomes

Preliminary 18-month safety and effectiveness results of RNS System responsive thalamic stimulation for the treatment of idiopathic generalized epilepsy (IGE)1

CAUTION Investigational device. Limited by U.S. law to investigational use for Idiopathic Generalized Epilepsy.

Meaningful Seizure Reduction

The NAUTILUS Study is the first and only neuromodulation randomized controlled trial (RCT) to demonstrate a statistically significant reduction in GTCs (Generalized Tonic-Clonic Seizures) for IGE patients2

77%
Median Reduction in GTCs
at 18-months
n=40 (p<0.001)

This reduction in GTCs was highly correlated with physician and patient Clinical Global Impression of Change

Clinical Global Impression of Change - Global Improvement

Breakthrough Evidence

The NAUTILUS study is the first-and-only RCT to demonstrate that IGE seizures can be safely detected and treated in the centromedian (CM) nucleus

Checkmark
Met Primary Safety
Endpoint
23
Sites across the
United States
87
Patients implanted
Icon

Breakthrough Device Designation

NeuroPace received an FDA Breakthrough Device Designation to study the treatment of drug-resistant IGE with the RNS system. This program is designed to accelerate access to treatment for patients with life-threatening conditions.

See the 18-month preliminary results.

See the data for yourself or watch the Webinar

SEE THE DATA WATCH THE WEBINAR
Image in support of the 18-month preliminary results

NAUTILUS STUDY News & Updates

News Image 2

December 21, 2023

Early Completion of Patient Enrollment

NeuroPace Announces Early Completion of Patient Enrollment in NAUTILUS Pivotal Study

Read more
News Image 3

October 11, 2022

First Patient Implanted in NAUTILUS Study

NeuroPace Announces First Patient Implanted in NAUTILUS Pivotal Study for the Treatment of Idiopathic Generalized Epilepsy (IGE)

Read more
News Image 4

March 31, 2021

Breakthrough Device Designation

The RNS System has been granted a Breakthrough Device Designation by the FDA to accelerate assessment and access for the treatment of drug-resistant IGE

Read more
News Image 5

November 10, 2021

NeuroPace Receives IDE Approval

NeuroPace Receives IDE Approval to Initiate NAUTILUS Pivotal Study of its RNS System for Idiopathic Generalized Epilepsy

Read more

Stay up to date on the latest IGE developments

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  1. Preliminary Safety and Effectiveness of RNS System Responsive Thalamic Stimulation for Treatment of IGE with GTCs: 18-Month Data, American Epilepsy Society, Dec 2025.
  2. Pre-specified additional effectiveness endpoint compared to baseline; pre-specified primary effectiveness not significant

CAUTION Investigational device. Limited by U.S. law to investigational use for Idiopathic Generalized Epilepsy. This preliminary clinical data is being shared for educational and scientific purposes only. The RNS System is not FDA approved for treatment of IGE.

®2025 NeuroPace, Inc. All rights reserved. NeuroPace and RNS are registered trademarks of NeuroPace, Inc., Mountain View, CA 94043. NP250142 Rev1 Date 2025-11

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Step 1 of 7

14%
    The RNS System is for individuals 18 and older who have focal epilepsy and have tried two or more medications without finding seizure control.

  • Based on your answers, your patient might benefit from the RNS System.

    Get your profile and a list of questions to ask your doctor.

  • Unfortunately it appears your patient is not an appropriate candidate for the RNS® System at this time.

  • The RNS® System is intended for patients who have undergone diagnostic testing that localized no more than 2 epileptogenic foci.

    If your patient has not undergone diagnostic testing, search here to find a comprehensive epilepsy center that can evaluate your patient, including determining if the RNS System is right for them.

  • If you are interested in learning more about the RNS® System, you can have an RNS® System professional contact you by filling out the form below:

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