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| |  Experimental Brain-Stimulation Device Benefits High Number of Responders: Presented at AES By John Otrompke BOSTON -- December 11, 2009 -- An investigational device demonstrates a high response rate in the use of neurostimulation to reduce partial-onset epileptic seizures, according to research from a recent clinical trial presented December 7 at the American Epilepsy Society (AES) 63rd Annual Meeting. “The device is placed at the seizure focus, directly into or on the surface of the brain, and monitors brain electrical activity,” explained Martha Morrell, MD, Stanford University, Palo Alto, California and NeuroPace Inc., Mountain View, California, the company developing the device. “The device is prompted to provide a pulse of stimulation where abnormal activity is detected.” A small computer identifies the unique electrical pattern that heralds the onset of a seizure in a given individual, Dr. Morrell noted, speaking here at a podium presentation. “The system watches the EEG [electroencephalogram], and when it sees the seizure signature, it can get the data from the [responsive brain-stimulation] system, or look on a computer or the website, and tell the device to detect it,” said Dr. Morrell. She noted that the system could normally store up to 2 seizure signatures at a time. In the trial, 191 patients with medically intractable partial-onset epilepsy were randomised to receive either an activated device or a device that had not been activated. People in the treatment group experienced a mean 29% reduction in seizures, compared with a 14% reduction in the sham stimulation group. At the end of the trial, patients experienced a median of 9.3 seizures per month. “We’ve known for a long time that when electrodes are placed to determine where the seizures come from, there is often a reduction in seizures. Nobody knows whether it’s from the placement or the anaesthesia,” said Dr. Morrell. “The placement of the [responsive brain-stimulation] system resulted in a decrease in seizures for the first 3 months, but the effect then wore off,” she commented. The overall seizure-free rate, however, was low at 11%, and there were 5 deaths in the study. One patient committed suicide, and 4 were possible or probable cases of sudden unexpected death in epilepsy patients (SUDEP). “Our results were within the expected rate for a patient population with severe epilepsy, given that the rate of SUDEP is expected to be 9.3 per 1,000 patients,” Dr. Morrell stated. Funding for this study was provided by NeuroPace Inc. [Presentation title: Pivotal Trial Data Demonstrate NeuroPace RNS System Reduced Seizures in People With Epilepsy. Abstract B.09]
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