Posts tagged RNS system
Articles and news from the latest research reports.
First Non-Study Site to Implant Device for Stopping Uncontrolled Seizures
NYU Langone Medical Center last month became the first hospital outside of a clinical trial site to implant a pacemaker-like device in the brain that may be a game-changer for patients with epilepsy.
The device, called the RNS System, was implanted April 17, 2014 in a patient with seizures that previously could not be controlled with medication, or intractable epilepsy, by Werner Doyle, MD, an associate professor in the Department of Neurosurgery at NYU Langone. The patient has recovered completely from the surgery.
The first-of-its-kind device is similar to an implantable cardioverter-defibrillator (ICD), which delivers electrical pulses to the heart to prompt it to beat a normal rhythm and provides a new alternative treatment to vagus nerve stimulation and surgical removal of the focus site – parts in the brain where the seizures originate — for people with intractable epilepsy.
Prior to last month’s surgery, the only implants of the seizure-reducing medical device took place at U.S. medical centers that had previously researched the device’s effectiveness and safety, making NYU Langone the first non-study hospital in the U.S. and New York metropolitan area to offer the RNS System to patients.
"Medically intractable epilepsy is often a debilitating disorder that puts sufferers at risk from sudden loss of consciousness and uncontrolled movements. It stigmatizes patients and restricts their independence," said Dr. Doyle. "Epilepsy surgery is an important therapeutic option for patients, which can significantly or completely control their seizures and return their lives to normal. The RNS device improves our ability to control seizures with surgery and now offers patients who may not have been surgical candidates in the past a surgical option."
According to the Centers for Disease Control and Prevention, about 2.3 million Americans suffer from epilepsy, with about one in 26 people expected to be diagnosed in their lifetimes. Approximately one-third of patients do not respond to medications and face major challenges with daily living. Uncontrolled seizures may interfere with normal activities such as working, going to school and driving. Patients also face increased risk for anxiety, depression, injury, brain damage, and in rare cases, death.
The RNS System, manufactured by NeuroPace Inc. of Mountain View, Calif., is a responsive stimulation device that’s implanted in the skull along with brain electrodes to detect abnormal electrical activity in the brain associated with seizures. After two or more weeks of recording the activity, doctors program the device to specifically respond to these abnormal signals by delivering imperceptible electrical pulses to the brain that normalize the activity. The device essentially “reboots” the portion of the brain where the seizure is originating, thereby effectively interrupting the abnormal electrical activity before it spreads or causes its unwanted effects.
The RNS System received pre-market approval from the Food and Drug Administration in November 2013 to treat patients’ seizures that have not been controlled by two or more antiepileptic medications.
In clinical trials performed at medical centers across the U.S., including at Saint Barnabas Medical Center in New Jersey by Dr. Doyle and Orrin Devinsky, MD, director of the Comprehensive Epilepsy Center at NYU Langone, 55 percent of patients experienced a 50 percent or greater reduction in seizures two years post implantation.
"The RNS System represents one of the most important and innovative therapies to treat people with epilepsy," says Dr. Devinsky. "This new surgical therapy uses information to target and shut down points in the brain where seizures start without removing tissue, providing a novel option for patients with uncontrolled seizures."
For more information:
Neurology, Morrell et al, 2011.
Newly-Approved Brain Stimulator Offers Hope for Individuals With Uncontrolled Epilepsy
A recently FDA-approved device has been shown to reduce seizures in patients with medication-resistant epilepsy by as much as 50 percent. When coupled with an innovative electrode placement planning system developed by physicians at Rush, the device facilitated the complete elimination of seizures in nearly half of the implanted Rush patients enrolled in the decade-long clinical trials.
That’s good news for a large portion of the nearly 400,000 people in the U.S. living with epilepsy whose seizures can’t be controlled with medications and who are not candidates for brain surgery.
Epilepsy is a chronic neurological condition characterized by recurrent seizures that disrupt the senses, or can involve short periods of unconsciousness or convulsions. “Many people with epilepsy have scores of unpredictable seizures every day that make it impossible for them to drive, work or even get a good night’s sleep,” said Dr. Marvin Rossi, co-principal investigator of the NeuroPace Pivotal Clinical Trial and assistant professor of neurology at the Rush Epilepsy Center.
The NeuroPace RNS System uses responsive, or ‘on-demand’ direct stimulation to detect abnormal electrical activity in the brain and deliver small amounts of electrical stimulation to suppress seizures before they begin.
The device is surgically placed underneath the scalp within the skull and connected to electrodes that are strategically placed within the brain where the seizures originate (called the seizure focus). A programmed computer chip in the skull communicates with the system to record data and to help regulate responsive stimulation.
The unique electrode placement planning modeling system developed at Rush uses a computer-intensive mapping system that facilitates surgical placement of electrodes at the precise location in the brain’s temporal lobe circuitry. When stimulated, these extensive epileptic circuits are calmed. The modeling system predicts where in the brain the activity begins and spreads, so that the device can better influence the maximal extent of the epileptic pathway.
The device also acts as an implanted EEG for recording brain activity. This function was first shown at Rush to help determine whether the patient will further benefit from a surgical resection, in which surgeons remove a portion of the temporal lobe network. Dr. Richard Byrne, chairman of Neurosurgery at Rush, implants the electrodes in the temporal lobes.
As a result, physicians at Rush can offer patients the new implantable neurostimulator device, a surgical resection or both with the possibility of completely eliminating seizures. “This device is also being used at Rush as a foundation and inspiration for building cutting-edge hybrid stimulation therapy-drug molecule delivery systems,” said Rossi.
“Devices that treat epilepsy may offer new hope to patients when medication is ineffective and resection is not an option,” said Rossi. “Not long ago, it was highly unlikely that these patients would ever be free of their seizures. Now, several of our Rush patients with this device are actually able to drive, lower or even eliminate their medications and aren’t as limited as they once were. There is no doubt that quality of life of the majority of our implanted patients is significantly improved.”
According to the Centers for Disease Control and Prevention, in 2010, epilepsy affected approximately 2.3 million adults in the U.S. and 467,711 children under the age of 17.
(Source: rush.edu)