Development of a Wearable Seizure Warning Device

DESCRIPTION (provided by applicant): In spite of advances in medical and surgical treatment, there are at any one time estimated to be some 350,000 individuals in this country whose seizures occur without warning and result in some combination of disordered thinking, impaired consciousness, or loss of motor control. Epileptologists and patients alike have long understood the magnitude of this problem and wished for a means of seizure warning that would allow self-protection or, in some cases, protective action on the part of caretaker. In spite of high perceived need and advances analytic and electronic technology, no seizure warning device exists that could be worn and used widely in situations that might range from children in a caretaker setting to independent adults in the workplace. We will design, test and manufacture a Wearable Seizure Warning Device (WSWD) by combining our experience in seizure warning (using scalp electrodes and some use of EKG) with state-of-the-art handheld wireless computer hardware/software and a digital EEG amplifier/transmitter of our own design. In Phase I, we propose to (1) optimize our seizure warning software parameters and algorithms for use in a WSWD environment, (2) port the seizure warning software to a handheld computer platform and evaluate its performance on prerecorded data, and (3) select an approach and perform an initial design for the amplifier hardware and interfaces. During Phase II the prototype hardware will be developed and clinically tested and the FDA approval phase initiated. Even with major advances in medical and surgical treatment for epilepsy, recurrent epileptic seizures remain a significant public health problem in the United States and around the world. When seizures occur in a critical setting, the person with epilepsy and those around him/her may be exposed to a high risk of injury, error, and embarrassment. During this project, over Phases I and II, we expect to develop a wearable seizure warning device that will be useful and acceptable to a significant portion of those patients whose seizures are not adequately controlled.