Open Competition 3 - Biotechnology
Preemptive Brain Stimulation Technology For Treating Epilepsy
Develop preemptive stimulation technology for use in an implantable neurostimulator that normalizes brain activity and reduces the likelihood and severity of epileptic seizures.
Sponsor: NeuroPace, Inc.1375 Shorebird Way
Mountain View, CA 94043
Epilepsy affects more than 2 million people in the United States and perhaps 50 million worldwide. Of the therapies for direct brain stimulation now being investigated to treat epilepsy, stimulation delivered in response to detected brain events is the most promising. A continuing clinical trial of an external responsive neurostimulator (RNS) developed by NeuroPace has generated data supporting the efficacy of responsive stimulation. The company has developed an implantable RNS. Under this ATP project, NeuroPace will develop preemptive stimulation technology for use in this implantable device that normalizes brain activity and reduces the likelihood and severity of epileptic seizures. Using a standardized database of human electrographic data and a novel computational approach, algorithms will be developed to detect abnormal electrographic brain activity and determine when to administer preemptive stimulation therapy in response. Research also will be conducted to show that preemptive stimulation using nonpulsatile waveforms is safe for humans. This proposal includes research subcontracts for electroencephalograph (EEG) analysis and clinical consulting. Additionally, the Center for Neural Recovery and Rehabilitation Research at Helen Hayes Hospital (West Haverstraw, NY) and the University of California at Los Angeles (Los Angeles, CA) will each provide animal research services. The primary risk in this proposal is development of detection/treatment algorithms and their use in delivery of the treatment to the area of the brain causing the seizure. Preferring less risk and a shorter time to commercialization, investors have declined to finance this project. Without ATP funding, the company would be unable to pursue this technology for three to five years. Patients suffering from intractable epilepsy (cases where drugs are inadequately effective or cause severe side effects) are the target population of NeuroPace's technology. In the United States, they number more than 1 million. For this group, the savings in combined medical and lost productivity costs from preemptive technology are estimated to reach $91 million by 2013. Preemptive neurostimulation technology also may have potential in other abnormal brain disorders, such as depression, bipolar disease, and schizophrenia.