Who is sponsoring this study?

The study sponsor is NeuroPace, a medical device company whose initial focus is the treatment of epilepsy. They are located in Mountain View, California and are a privately-held company with approximately 80 employees. Further information can be found at www.neuropace.com

What are seizures?

Seizures occur when an abnormal electrical discharge in the brain causes a change in awareness, movement, sensation or other brain function. A seizure begins when a tiny cluster of brain cells or neurons gets overexcited. As a result, other cells in the brain begin to “fire” rapidly in a rhythmic and synchronized repetition that sends mixed signals to the brain, causing a seizure. The condition in which seizures are recurring is called epilepsy.

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What are the current treatment options?

Most seizures are controlled by antiepileptic drugs. The type of medication prescribed depends on the frequency and severity of the seizures and the person's age, overall health and medical history.

About 30% to 40% of patients have seizures that can’t be controlled with drugs. Some of these patients may be candidates for epilepsy surgery. Different surgical procedures have been developed for specific types of epilepsy. In the most common surgical procedure, the area of the brain that triggers the seizures is removed. Other procedures cut the nerve fibers connecting parts of the brain.

Direct brain stimulation may be another way to treat epilepsy. It is already being used to treat persons with Parkinson’s disease and severe tremors. Neurostimulation is also used to treat pain.

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What is responsive stimulation?

Responsive stimulation is controlled stimulation sent to the area of the brain that triggers the seizure, attempting to stop the seizure before symptoms occur. Stimulation occurs when seizure activity is detected in the brain.

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How does the NeuroPace RNS^™ System work?

The RNS neurostimulator is a small device that is implanted in the head. The device is powered by a battery and contains a computer chip that detects and stores a record of your brain’s electrical activity.

When the device identifies seizure activity, it attempts to stop the seizure by sending electrical stimulation through the leads to a small part of your brain. This type of treatment is called responsive stimulation.

After the device is implanted, the study physician uses the programmer to look at information stored in the device about your detections and stimulations. The study physician can also look at records of your actual brain electrical activity. This information helps the study physician select the best detection and stimulation settings for you. The programmer is then used to program the detection and stimulation settings in the neurostimulator.

The data transmitter (or DTR) is used by you to provide information to the study physician. You use a wand to transfer information from the neurostimulator to the DTR. You then connect the DTR to a phone line and information is provided to your study physician via a protected website. Your study physician can look at your response to stimulation and decide on the best seizure detection and stimulation settings for you.

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How is the RNS^™ System implanted?

The system is implanted by a study physician during a two- to five-hour procedure that occurs while you are asleep. Two to four leads are placed in the brain where the seizures start. Then the neurostimulator is placed in the skull. After the procedure, you will typically stay in the hospital one to three days.

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Is financial compensation provided? Are there costs for participating in the investigational clinical research study?

Participants will not have to pay for any medical care they get from the study except for any co-payments or other cost-sharing payments required by the participant’s health insurance plan.

To help cover out-of-pocket expenses, participants will be paid $25.00 for each required study visit. Additional financial assistance may be available to eligible participants through foundations and other third party organizations.

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If I participate, what are the requirements?

All study participants will keep a seizure diary. Participants are eligible for implantation once the seizure diary shows an average of three or more seizures per month over three consecutive months with a minimum of two seizures in any one month. Participants may then undergo the implantation procedure. After implantation of the RNS System, participants will continue to keep a seizure diary and will have office visits with the study physicians at regular intervals for approximately one year and will then be followed less frequently for another year.

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Will the device cause temporary or long-term side effects?

As with any medical device and/or procedure, there are risks and side effects that may not be known at this time. All currently known risks are described in the informed consent form that must be signed before you may participate in the study. Precautions will be taken to monitor findings during the study that may affect your willingness to continue to participate in the study. Your physician will inform you of significant new findings that may affect your willingness to continue participation in the study.

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Will my medical information be kept confidential?

Every effort will be made to keep all information about you private. Your name will not appear in any publications or reports about this study.

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Are clinical research studies safe?

The U.S. Food and Drug Administration (FDA) has strict regulations and safeguards in place to protect people who choose to participate in clinical trials. The FDA must approve clinical trials that present significant risk to patients. Additionally, every clinical trial in the U.S. must be reviewed and approved by an Institutional Review Board (IRB) representing the study site. The purpose of an IRB is to protect the rights and safety of people who volunteer to take part in research studies. Before participating in a trial, a person must read and sign an informed consent form, which provides detailed information about the study procedures, and study risks and potential benefits, if any. Experienced physicians who have been thoroughly trained are designated as investigators for the study. These investigators (physicians), who specialize in a specific condition or disease, administer the study procedures and closely monitor study participants. For more information on clinical research trials, visit: www.clinicaltrials.gov/ct/info.

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Where is the study being conducted?

Phoenix, AZ
Los Angeles, CA
San Francisco, CA
New Haven, CT
Washington, DC
Jacksonville, FL
Miami, FL
Atlanta, GA
Augusta, GA
Chicago, IL
Indianapolis, IN
Wichita, KS
Boston, MA
Baltimore, MD
Detroit, MI
Rochester, MN
Lebanon, NH
New York, NY
Rochester, NY
Cleveland, OH
Portland, OR
Philadelphia, PA
Charleston, SC
Dallas, TX
Houston, TX
Charlottesville, VA
Seattle, WA
Madison, WI.

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