Study Posting (4283) -- Trial #115762, Epilepsy, Indianapolis, IN

NeuroPace, Inc is sponsoring an investigational device study of the Responsive Neurostimulator (RNS™) system, the company's responsive brain stimulation therapy for refractory epilepsy. The RNS Pivotal Clinical Investigation is designed to assess the safety and to demonstrate that the Responsive Neurostimulator (RNS™) system is effective as an add-on (adjunctive) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory (resistant or hard to treat) to two or more anti-epileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.

The RNS Pivotal Clinical Investigation is a randomized, double-blind, sham stimulation controlled investigation being conducted at approximately 28 sites throughout the United States. The investigation is designed to assess the safety and effectiveness of responsive brain stimulation (delivered by the RNS device) in reducing the frequency of medically uncontrolled partial onset seizures (those that start from one area of the brain).

The responsive neurostimulator and leads are implanted in the head. The RNS (a pacemaker-like device) has a small battery for power and a microprocessor that detects (senses) and stores electrical activity from the brain. When the RNS detects a seizure, it responds by sending electrical stimulation through leads (tiny wires with electrodes) to a small part of the patient's brain to stop the seizure. This type of treatment is called responsive stimulation, but it is not yet known if it will work for the treatment of epilepsy. Direct brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Direct brain stimulation is not approved for the treatment of epilepsy.

Study participation is expected to last approximately two (2) to three (3) years. All participants in the trial will be implanted with the RNS device. During the double-blind portion of the trial, half of the participants will have responsive stimulation turned ON and half will have responsive stimulation turned OFF. Participants will not know whether stimulation is being delivered or not. Five months after the RNS has been implanted, when the double-blinded portion of the trial is completed, all participants will be able to have stimulation turned ON. Seizure frequency and severity, as well as physical and emotional health will be followed throughout the study.

1. Disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in areas such as employment, psychological or social wellbeing, or in mobility.
2. Failed treatment with a minimum of two anti-seizure medications.
3. An average of three or more seizures every 28 days for three consecutive 28-day periods.
4. Between the ages of 18 and 70 years.
5. No more than two epileptogenic brain regions.

Note: Patients with vagus nerve stimulators may be eligible for this clinical trial if the device has been turned off for a specified period of time and the patient agrees to have the generator explanted (excluding leads) prior to or at the time of the RNS implant.

If you meet these criteria and would like more information, you or your physician can contact one of the participating clinical trial sites.

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Trial Information

Summary: RNS™ System Pivotal Clinical Investigation