The electroencephalogram (EEG) electrode is a critical component for diagnosing and understanding neurological phenomenon. Electrode placement on the scalp is currently problematic, time consuming, and labor intensive. In partnership with Baltimore Biomedical, Inc., a novel self-installed electrode technology was developed and patented as part of a prior NIH SBIR program and uses hair to anchor the electrode near the scalp. Based on this prior art, Key Technologies, Inc. has conceived and developed an electrode placement system specifically to support studies in multi-electrode environments (such as EEG laboratories, sleep centers, and growing markets such as ambulatory monitoring, gaming, and critical care). The new system consists of a disposable electrode and a reusable installation tool. This system has been proven through a now complete Phase I NIH SBIR. Analytical and qualitative analyses have shown system performance to be equal to the gold cup standard in signal shape, amplitude, spectral power density, and artifact density. This design uniquely provides the ability for quick placement of multiple electrodes via a single, hand-held installation tool without the need for messy adhesives or excess electrolyte. The small size, high comfort level, and quick placement attributes make the system ideal for critical care, EEG, anesthetics, and extended monitoring in which multiple electrodes are required. Unlike the current industry standard, the electrode will be disposable, a desirable attribute with the current concern to control the spread of communicable diseases. The project goals, through Phase III, are to design, prototype, validate, market, manufacture, and commercialize this novel electrode system. To date, preliminary prototype designs have been completed and validated through Phase I clinical trials. Phase II will focus on the following tasks: refinement of the mechanical design, development of a custom electrolyte to enhance long term performance, advancement of the tool design to incorporate multiple electrodes, and thorough clinical trials to prove performance across a broad demographic spectrum.
