Clinical Study

For teens aged 12 through 17 years

Clinical Study

For teens aged 12 through 17 years

Photo of two young people enjoying music

If medications are not providing seizure control, the RESPONSE Study may be the right next step.

This research study is evaluating the safety and effectiveness of the NeuroPace RNS® System as a treatment option for drug-resistant, focal epilepsy in patients aged 12 through 17 years.

CAUTION—Investigational device. Limited by United States law to investigational use for the following Indications for Use:
The RNS System investigational intended use is as an adjunctive therapy in reducing the frequency of seizures in individuals 12 through 17 years of age with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).

Find out if your teenager could be eligible for the RESPONSE Study.

Children’s Hospital of Orange County (CHOC)
Orange, CA 92868
Study Coordinator: Angelyque Lorenzana
Email: Angelyque.Lorenzana@choc.org
Phone: 714-509-8972. ext.18972

Nicklaus Children’s Hospital
Miami, FL 33155
Study Coordinator: Mari Vega
Email: Marinellie.Vega@Nicklaushealth.org
Phone: 786-624-3516

University of Chicago
Chicago, IL 60637
Study Coordinator: Christine Herrera
Email: crodriguez6@bsd.uchicago.edu
Phone: 773-702-2256

Spectrum Health
Grand Rapids, MI 49503
Study Coordinator: Shannon Emrich
Email: Shannon.Emrich@spectrumhealth.org
Phone: 616-391-0174

Mayo Clinic Minnesota
Rochester, MN 55905
Study Coordinator: Bridget Neja
Email: Neja.Bridget@mayo.edu
Phone: 507-538-0266

New York Medical College/Westchester Medical Center
Hawthorne, NY 10532
Study Coordinator: Donika Zogejani
Email: dzogejan@nymc.edu
Phone: 914-768-3970

Cohen’s Children’s Medical Center
Lake Success, NY 11042
Study Coordinator: Aaqil Ali
Email: aali27@northwell.edu
Phone: 631-290-1193

Mount Sinai Beth Israel
New York, NY 10029
Study Coordinator: Armand Harb
Email: Armand.Harb@mountsinai.org
Phone: 212-241-2524

LeBonheur Children’s Hospital
Memphis, TN 38103
Study Coordinator: Nick Leal
Email: Nicolas.Leal@lebonheur.org
Phone: 901-287-5886

Graphic illustrating multiple medications

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.

What is the RNS System?

The RNS System is a medical device designed to treat drug-resistant focal epilepsy. The RNS System consists of an implantable neurostimulator and small wires (called leads). The leads are placed on and/or inside the brain where seizures start. Once placed, the device is designed to be unnoticed by others.

RNS product image

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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FAQs

Why is this study being done?

The purpose of the RESPONSE Study is to demonstrate whether the NeuroPace RNS System is safe and effective (works well) as an additional treatment in patients implanted at ages 12 through 17 who have drug-resistant focal 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 take part in this study you will be asked to do the following:

  • Enter information in an electronic diary every day.
  • Attend all study visits (~3-4 times a year, in-person or telehealth) and complete all study activities.
  • 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 to send information to your doctor.

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Thanks for your interest in the RESPONSE Study. Eligibility to participate in the RESPONSE Study is based on a specific set of criteria. If you or a loved one meet the initial set of study eligibility criteria, we may share your contact information with a study center close to you.
How old is the potential study participant?








Has the individual been diagnosed with epilepsy?
Does the individual experience 3 or more disabling seizures per month?
How many antiseizure medications have been tried?
Does this individual have focal epilepsy?
Focal epilepsy seizures start in one part of the brain and can spread to the rest of the brain.
Is this individual currently participating in an investigational drug or device study?
Based on these responses, you may be a candidate for the RESPONSE Study. Are you interested in being contacted to learn more about the RESPONSE Study?





If you check the box below, we will contact you about the NeuroPace RNS System and any appointments you choose to book with us.
Unfortunately, it appears the potential study participant is not an appropriate candidate for the RESPONSE Study.  The study is evaluating the safety and effectiveness of the NeuroPace RNS System as a treatment for drug-resistant, focal epilepsy in patients aged 12 through 17. We suggest you discuss potential treatment options with your physician.



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:

  • By filling out this form, you are agreeing to the terms of our privacy policy. This form is intended for US residents only.

    By clicking submit, you are agreeing to receive communications from NeuroPace. You can unsubscribe at any time.

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