Improved EEG Patient Interface

DESCRIPTION (PROVIDED BY APPLICANT): The long-term goal of this SBIR is to minimize noise interference and improve patient mobility during Electroencephalogram (EEG) procedures with a new lightweight head-worn interface. EEG recordings are routinely used in diagnosing and evaluating many neurological disorders including epilepsy, sleep apnea, and encephalitis. Existing EEG instruments include sophisticated hardware and software, but they are still severely limited by inadequate interfaces between the electrodes on the patient's scalp and the measurement system. This restricts mobility, compromises signal integrity, and compromises connection reliability. BIOMEC proposes to design a miniaturized amplifier/processor circuit mounted on flexible boards in the shape of a light and thin headband worn by the patient. The headband will wirelessly interface with a PC thereby eliminating intermediate computer cards and bulky cabling. The Phase I project designed a 32- channel miniature system, constructed a single channel prototype, and tested the concept on the bench and on five patients with results that met or exceeded expectations. The Phase II project optimized the circuit board layout, designed preliminary headband packaging, developed firmware and software, manufactured prototypes, and tested the complete system on 12 patients. This Phase II Type 2 proposal will reduce the size of the headband even further, enhance the hardware, make the system completely wireless, enhance the firmware and software, finalize the system packaging, create pre-production prototypes, conduct all the safety testing required by the FDA, and submit a FDA 510(k) application.