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Research - Responsive Neurostimulator (RNS) System Feasibility Clinical Investigation

Figure 1: EEG recorded from the RNS device showing the termination of a seizure after stimulation. (Reference: www.neuropace.com)

The RNS system is a new way to try to control seizures. The RNS is an implantable device, manufactured by NeuroPace, Inc., which detects and responds to seizure activity. The RNS contains a small battery for power (changed every 3-5 years) and a microprocessor (computer chip) that detects and stores electrical activity from the brain. When the RNS detects a seizure, it responds by delivering electrical stimulation through the lead(s) (electrodes) to a small part of the brain to try to stop seizures. This type of therapy is known as responsive stimulation and has not yet been shown to work in treating epilepsy. The RNS system is being studied by NeuroPace and the LSUHSC Epilepsy Center of Excellence.

RNS Device: Actual size of stimulator is 4.15 cm (w) x 6.00 cm (l) x 0.838 cm (d)

The purpose of the RNS System Feasibility Clinical Investigation is to find out how well this implanted, investigational device works in treating seizures. Persons with epilepsy may be a candidate to participate if they have at least 4 seizures per month, their seizures have not been effectively controlled by antiseizure medication or they do not tolerate antiseizure medication, and they have undergone testing to determine the area in the brain where their seizures start. The first two criteria are determined through participation in another study (the Prospective Seizure Frequency Clinical Investigation) and the last criterion is determined through localizing procedures, such as MRI (magnetic resonance imaging), PET (positron emission tomography) and 24-hour video/EEG monitoring.

The LSUHSC Epilepsy Center has one patient with an implanted RNS, but we are not able to offer new implants at this time.