U44NS121559

PROJECT SUMMARY Electroencephalography (EEG) is an essential component in the evaluation of epilepsy, the most common serious brain disorder worldwide. Misdiagnosis of epilepsy is very common and occurs in up to 50% of the patients. Artifact contamination seriously hinders the effectiveness of EEG and is a root cause of misdiagnosis. CREmedical is developing a tripolar concentric ring electrode (TCRE) sensor and a t-Interface that registers tripolar EEG (tEEG) and emulated EEG (eEEG). tEEG resolves the fundamental drawbacks of conventional EEG, providing significant improvement in signal fidelity, spatial resolution, and registering of higher frequency brain activities, where conventional EEG is lacking. There is increasing interest in the epilepsy community in analyzing high-frequency oscillations (HFOs) for localizing epileptogenic zones. The overall objective of this SBIR fast-track project is to complete the necessary non-clinical and clinical activities in order to enable the transition of the device from lab to clinical use. This project integrates multidisciplinary expertise in technology, epilepsy, neurophysiology, and regulatory affairs. The Phase I objective is to complete the non-clinical development activities necessary for commercialization and obtaining IRB approval for initiating a clinical trial in epilepsy. Ph I - Milestone 1: Obtain clear non-binding indication from the FDA that our proposed clinical trial protocol is likely sufficient to obtain a 510 (k) regulatory clearance. Ph I - Milestone 2: Obtain IRB confirmation that the proposed pre-clinical testing and clinical protocol are appropriate to support the non-significant risk (NSR) clinical trial. Ph I - Milestone 3: Develop head phantom and computer simulation to test contribution of local reference. Ph I - Milestone 4: Establish Design and Quality Systems Control process. Ph I - Milestone 5: Perform design verification and validation in pursuant to regulatory and industry standards. The Phase II objective is to demonstrate the safety and efficacy of the tEEG device in recording electrical brain activities in persons with epilepsy in preparation for obtaining FDA clearance. Ph II – Milestone 1: Proven usability. (A) Do EEG technologists have problems applying and removing the TCREs? (B) Are the tEEG and eEEG data interpretable? (C) Can tEEG and eEEG record patterns that are also visible with concurrent conventional EEG? Ph II – Milestone 2: Superiority of tEEG for artifacts suppression. Ph II – Milestone 3: Superiority of tEEG for seizure detection. Ph II – Milestone 4: Comparison between simultaneous intracranial recordings and tEEG for seizure localization.PROJECT NARRATIVE 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 may advance diagnosis and fill unmet clinical and research needs. Commercially, tEEG promises to transform the market landscape and set a new standard for EEG equipment.