U44NS121559

Epilepsy Seizure Detection with Innovative Tripolar EEG (TEEG) - 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.

Phase 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.

Phase 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.

Phase I - Milestone 3: Develop head phantom and computer simulation to test contribution of local reference.

Phase I - Milestone 4: Establish design and quality systems control process.

Phase 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.

Phase 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?

Phase II - Milestone 2: Superiority of TEEG for artifact suppression.

Phase II - Milestone 3: Superiority of TEEG for seizure detection.

Phase II - Milestone 4: Comparison between simultaneous intracranial recordings and TEEG for seizure localization.

Cremedical

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Rhode Island United States

State-Wide

Translational Neural Devices (U44 - Clinical Trial Required) (RFA-NS-18-012)

Amendment Since initial award the End Date has been extended from 07/31/26 to 07/31/27 and the total obligations have increased 245% from $722,251 to $2,490,741.