New research study investigating a treatment for Idiopathic Generalized Epilepsy

If you still experience seizures despite taking medications, there is a new epilepsy clinical study available for individuals 12 years and older with hard-to-treat idiopathic generalized epilepsy (also called primary generalized epilepsy).

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

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About IGE Epilepsy | NAUTILUS Study | The RNS® System | FAQ

What is Idiopathic Generalized Epilepsy (IGE)?

Individuals with idiopathic generalized epilepsy can experience generalized tonic clonic seizures (also known as convulsions or grand mal seizures), myoclonic seizures, and absence seizures.

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.

SEE IF YOU COULD BE ELIGIBLE FOR A CLINICAL STUDY TO TREAT IGE

About the NAUTILUS Study

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The NAUTILUS 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 who currently have generalized tonic clonic seizures, with or without myoclonic or absence seizures.

lf 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.

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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.

If your current epilepsy treatment is not working, a clinical study of neurostimulation for drug-resistant IGE may be an option

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.

30% of people with epilepsy still experience uncontrolled seizures despite taking anti-seizure medicine. lf your current epilepsy treatment is not working, you are not alone. A clinical study investigating responsive neurostimulation to treat drug-resistant idiopathic generalized epilepsy may be an option.

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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 the NAUTILUS 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

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 NAUTILUS 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.