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The RNS System is an investigational device made up of the responsive neurostimulator and leads (tiny wires with electrodes). The RNS System also includes a programmer for the study physician and a data transmitter for you to provide information from your neurostimulator to the study physician.
The RNS neurostimulator is a small device that is implanted within the skull by a study physician. 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 suppress the seizure by sending electrical stimulation through the leads to a small part of your brain. The stimulation settings are selected so that stimulation cannot be felt. This type of treatment is called responsive stimulation.
The physician operated programmer communicates with the RNS neurostimulator via a hand-held wand. 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 is then able to view your response to
the stimulation and decide on the best seizure detection and stimulation
settings for you.
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.
The RNS System is currently being evaluated to determine how well it can reduce the frequency of uncontrolled seizures. It is approved by the FDA only for use in clinical research studies.
