SBIR Phase II: Innovative Electroencephalography to Advance the Research and Diagnosis of Brain Disorders

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is multi-fold: First, the proposed tripolar concentric ring electrode and instrumentation for acquiring brain signals, tripolar electroencephalography (tEEG), is a platform technology that has a variety of medical and commercial applications. By providing significantly clearer brain signals, tEEG will resolve conventional EEG?s major drawback of poor signal quality that clinicians and researchers have been struggling with for decades. tEEG can advance diagnosis and fill unmet clinical and research needs such as detection of biomarkers to quantify various neurological disorders. Second, commercially, tEEG can transform the market landscape and set a new standard for EEG equipment. The fundamental improvement promised by tEEG and its non-invasive nature are particularly appealing. tEEG could greatly simplify and advance the diagnosis of a wide spectrum of neurological disorders (epilepsy, sleep disorders, stroke, Parkinson?s, Alzheimer?s, etc.) and more effectively guide neurosurgical and other medical procedures. Third, the fundamental improvement in spatial resolution and artifacts rejection in EEG signals will help advance the understanding of brain activity, leading to new discoveries in the research of various brain diseases and neurological disorders. The proposed project aims to develop a portable tripolar concentric ring electrode (TCRE) electroencephalography (tEEG) recording system and perform a comprehensive clinical evaluation to demonstrate that tEEG can detect certain important brain EEG signals better than conventional EEG. EEG is the primary diagnostic tool for epilepsy, the most common serious brain disorder worldwide, but misdiagnosis occurs in up to 50% of the patients. Artifact contamination seriously hinders the effectiveness of EEG and is a root cause of misdiagnosis. tEEG automatically suppresses artifacts and increases the interpretability of EEG through two inventions: (1) a transformative electrode configuration - the TCRE; and (2) the proprietary tEEG Interface and digitizer. The TCRE, tEEG Interface, and digitizer together comprise a complete, Portable tEEG system with the data stored and displayed on a laptop. In this project, clinicians will evaluate tEEG against conventional EEG in areas such as usability, ability to suppress artifacts, and superiority in seizure detection. If successful, tEEG would generate intense interest in the field because of the significant clinical and research impact. We expect that comparing tEEG and EEG in a clinical setting will demonstrate the superiority of tEEG for diagnosing epilepsy.