NAUTILUS
Clinical Study

For individuals 12 years and older with hard-to-treat idiopathic generalized epilepsy (IGE), which is also called primary generalized epilepsy.

Find out if you could be eligible for the NAUTILUS Study.

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If you have been diagnosed with IGE and still have seizures after trying 2 or more anti-seizure medications, you may be eligible for the NAUTILUS Study.

This research study is evaluating the safety and effectiveness of thalamic stimulation with the NeuroPace RNS System as an additional treatment in reducing the frequency of primary generalized seizures in people 12 years and older with drug-resistant idiopathic generalized epilepsy. Specifically this study will involve participants with IGE whose seizures have not been controlled by antiseizure medications and currently have primary generalized seizures (generalized tonic clonic seizures, with or without myoclonic or absence seizures).

CAUTION—Investigational device. Limited by United States law to investigational use for the following Indications for Use: The RNS® System is intended for thalamic stimulation as an adjunctive therapy for the treatment of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.

What is Drug-Resistant Epilepsy?

If you have tried at least two anti-seizure medications and still experience seizures, you may have drug-resistant epilepsy. Doctors may also refer to this type of epilepsy as refractory, intractable, hard-to-treat, or uncontrolled seizures. Over 1 million people in the U.S. are living with drug-resistant epilepsy.

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What is the RNS System?

The RNS System is a medical device that is FDA approved for the treatment of drug-resistant focal epilepsy (also called partial onset epilepsy). The RNS System consists of an implantable neurostimulator and small wires (called leads). In this study, one lead will be placed in the left side of the brain within an area called the centromedian nucleus of the thalamus, and the other lead will be placed in the right centromedian nucleus of the thalamus. Once placed, the device is designed to be unnoticed by others.

How Does the RNS System Work?

  • It monitors brain activity continuously
  • It is programmed to recognize and respond to your brain patterns, sending brief stimulation to help prevent seizures before they start.
  • It records and reports your EEG information for your doctor to review.
How the RNS System Works
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Ready to see if you may be eligible?

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FAQs

What is Idiopathic Generalized Epilepsy (IGE)?

Idiopathic means that your doctor cannot find anything in your brain that is causing your seizures. Generalized epilepsy is when seizures affect both sides of your brain at the same time and for the purposes of this study includes generalized tonic clonic seizures (also known as convulsions or grand mal seizures), with or without myoclonic or absence seizures.

Why is this study being done?

The RNS System is already approved by the FDA to treat some types of focal epilepsy, but it has not been approved for other types of epilepsy. The purpose of the NAUTILUS Study is to see if the RNS System is safe and effective (works well) as an additional treatment in reducing the frequency of primary generalized seizures in individuals 12 years and older who have drug-resistant idiopathic generalized epilepsy.

How long will I be in this study?

You will be in the RESPONSE Study for 2 years after you are implanted with the RNS System.

What are my responsibilities if I take part in this study?

If you are enrolled in the NAUTILUS Study, you will be asked to do the following:

  • Enter your seizure information in an electronic diary every day.
  • Attend all study visits (3-4 times per year) for 2 years and complete all study activities. The first year the study doctor will see you in-person for appointments, and in the second year, some of your visits may be done in-person, by telehealth or by telephone.
  • Tell the study team about any side effects, illnesses and injuries (including hospitalizations) you have while you are in the study.
  • Use the NeuroPace Remote Monitor as instructed to send information from your device to your doctor.