UG3NS120172

Advancing Epilepsy Diagnosis with Flexible, High-Resolution Thin-Film Electrodes - Project Summary

To advance the development of next-generation personalized therapies for long-term seizure freedom, we urgently need technologies that improve seizure diagnostics while reducing risks associated with invasive neurosurgical procedures.

Among the more than 1,000,000 Americans with uncontrolled focal epilepsy, many have poorly localized seizure foci. These individuals face the highest rates of 'failure' (i.e., ongoing seizures) after epilepsy surgery. That failure reflects the biology of their epilepsy as well as the overlap of seizure foci with essential cortical areas. However, limits of current technologies also play a critical role in the high failure rate as we are currently limited in our ability to sample wide regions of the neocortex (i.e., stereoEEG) or to record broad neocortical regions without inducing pain, swelling, and neuroinflammatory tissue damage (i.e., subdural grid and strip recordings).

To meet this need for safer, more effective invasive electrode studies and simultaneously enable discovery to advance next-generation therapies, this UG3/UH3 clinical trial project leverages a successful, long-term collaboration between clinicians, engineers, material scientists, neuroscientists, and industrial partners at New York University School of Medicine, New York University, Duke University, the University of Utah, Blackrock Microsystems, and Dyconex to translate modern thin-film technology into next-generation FDA-approved implantable neurological devices.

We have developed and extensively tested a novel electrode array based on liquid crystal polymer thin-film (LCP-TF) technology with partner Dyconex, AG. When combined with large-scale data acquisition systems, LCP-TF electrodes will provide higher quality neural recordings than existing FDA-approved electrode arrays, with improved safety and at an affordable cost.

We propose to obtain traditional 510(k) approval from the FDA for short-term implantation (<30 days) of LCP-TF electrodes to (1) improve surgical tolerability for patients with neocortical, focal, drug-resistant epilepsy undergoing invasive electrode studies and (2) advance diagnostic capabilities to determine the location of seizure foci.

Our preliminary work in a non-human primate animal model led to a prototype device nearly identical to the final device design planned for clinical testing. This work establishes supporting data for entry into preclinical testing in the 3-year UG3 phase (Aims 1-3) that will lead to 510(k)-approved devices (Aim 4) for a single-site, randomized-controlled pilot clinical trial in the 2-year UH3 phase (Aim 5) that will test the hypothesis that performing epilepsy diagnostic studies with LCP-TF electrodes, compared to CG electrodes, improves both surgical tolerability and diagnostic effectiveness.

These efforts will advance the development of next-generation precision approaches to treating epilepsy as well as support future development of LCP-TF electrodes for other neurological disorders. Low-cost, FDA-approved LCP-TF electrodes have the potential to revolutionize the treatment of a wide range of neurological disorders.

New York University

(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.

93.372 - 21st Century Cures Act - Brain Research through Advancing Innovative Neurotechnologies

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

New York, New York 100164852 United States

Single Zip Code

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required) (RFA-NS-18-021)

Amendment Since initial award the End Date has been extended from 02/28/25 to 08/31/26 and the total obligations have increased 2482% from $138,946 to $3,587,136.