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.
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
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.
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.
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.
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.
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.
You will be in the NAUTILUS Study for 2 years after you are implanted with the RNS System.
If you are enrolled in the NAUTILUS Study, you will be asked to do the following:
