This Small Business Innovation Research Phase I project aims to establish the feasibility of innovative tripolar concentric ring electrode electroencephalography (tEEG) for epilepsy diagnosis. Epilepsy is the most common serious brain disorder worldwide. Presently, EEG is the primary diagnostic tool for epilepsy, but misdiagnosis occurs in up to 50% of the patients. The root cause of misdiagnosis lies in the poor signal fidelity of EEG which stems in part from signal contamination with noise. The proposed tEEG technology achieves superior signal fidelity through two inventions: (1) the tripolar concentric ring electrode (TCRE), a transformative electrode configuration which overcomes the limitations of the conventional electrode; and (2) a proprietary interface circuit which serves as a preamplifier to conventional EEG amplifiers. This project will accomplish two specific aims. The first aim is to improve the design of the clinical tEEG prototype. The second aim is to evaluate tEEG against conventional EEG in adult and pediatric patients with epilepsy. Success will be determined by expert review and quantitative analysis. tEEG is expected to exhibit higher interpretability and quantitative performance than conventional EEG, helping improve epilepsy diagnosis.
The broader impact/commercial potential of this project is three-fold: (1) Commercial Value. tEEG is a platform technology that has a variety of medical and commercial applications. By providing significantly higher fidelity which leads to improved signal interpretability, tEEG will resolve conventional EEG?s major drawback and a fundamental problem that clinicians and researchers have been struggling with for decades. tEEG can advance diagnosis and fill unmet clinical and research needs. Commercially, tEEG can transform the market landscape and set a new standard for EEG equipment. (2) Societal Impact. The fundamental improvement promised by tEEG and its non-invasive nature are particularly appealing. tEEG has the potential to greatly simplify and advance the diagnosis of a wide spectrum of neurological disorders and more effectively guide neurosurgical and other medical procedures. (3) Enhanced Scientific and Technological Understanding. tEEG can benefit a host of brain and behavioral research areas. The fundamental improvement in signal fidelity and artifacts rejection will help advance the understanding of brain activity, leading to new discoveries in the research of various brain diseases and neurological disorders. The increased signal fidelity from tEEG may advance research of biomarkers to quantify neurological disorders with tEEG which was not previously possible.
This Small Business Innovation Research Phase I/IB project established the technical and commercial feasibilities of using innovative tripolar concentric ring electrode electroencephalography (tEEG) to assist epilepsy diagnosis in a clinical setting. Epilepsy is the most common serious brain disorder worldwide. Presently, EEG is the primary diagnostic tool for epilepsy, but misdiagnosis occurs in up to 50% of the patients. The root cause of misdiagnosis lies in the poor sensitivity/specificity of EEG which stems in part from its low signal-to-noise ratio (SNR). tEEG achieves higher SNR through two inventions: (1) the tripolar concentric ring electrode (TCRE), a transformative electrode configuration which overcomes the limitations of the disc electrode; and (2) a proprietary TCRE interface circuit which serves as a preamplifier to conventional EEG amplifiers. Intellectual Merit Seizure onset often is obscured by movement and muscle artifacts. During the Phase I/IB project, tEEG demonstrated its ability to automatically attenuate myogenic activity and movement artifacts. The massive myogenic activity during seizures heavily contaminated EEG whereas signals recorded with tEEG were sharp and clear. The high fidelity provided by tEEG suggests that spike and seizure detection and high frequency oscillations (HFOs) could be enhanced with tEEG. Electrophysiological biomarkers of epileptogenic brain and precursor signals such as HFOs that precede the onset of clinical seizures may lead to improvements in the efficacy of epilepsy surgery and brain stimulation. However, it is very difficult and unreliable to record HFOs with scalp EEG. Most HFOs are recorded on invasive intracranial EEGs. Intracranial EEG is a highly invasive and costly procedure, with significant risk to the patient. Development of less invasive methods to monitor seizure activity or guide surgery is an important direction in epilepsy. It is very exciting that, during the Phase I/IB project, the noninvasive scalp tEEG identified HFOs at five minutes to an hour prior to the seizure onset in all five patients from whom seizures were recorded. Broader Impacts Epilepsy was selected as the area for evaluation in this Phase I/IB project because epilepsy is the most common serious brain disorder worldwide and is one area where diagnosis is critically limited by the deficiencies in conventional EEG. Advances gained in epilepsy diagnosis due to tEEG will likely translate to other brain disorder fields, which present additional investigative areas in the future. Potential Commercial Value: tEEG is a platform technology that has a variety of medical and commercial applications. By providing significantly higher fidelity which leads to improved sensitivity/specificity, tEEG will resolve conventional EEG’s major drawback and a fundamental problem that clinicians and researchers have been struggling with for decades. tEEG can advance diagnosis and fill unmet clinical and research needs. Commercially, tEEG can transform the market landscape and set a new standard for EEG equipment. Societal Impact: 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. Enhanced Scientific and Technological Understanding: tEEG may benefit a host of brain and behavioral research areas. The fundamental improvement in SNR 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 increased signal fidelity from tEEG may advance research of biomarkers to quantify various neurological disorders (such as autism) with tEEG which was not previously possible.
