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Principal Investigator: Rajmohan Bhandari
Organization: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Fiscal Year: 2024
Award: $1,608,204
Funding agency: National Institute of Neurological Disorders and Stroke
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 safely 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
Terms: <Abscission><Acceleration><Advanced Development><Affect><American><Animal Model><Animal Models and Related Studies><Area><Artifacts><Biology><Bleeding><Body Tissues><Brain><Brain Nervous System><Cell Communication and Signaling><Cell Signaling><Clinical><Clinical Evaluation><Clinical Testing><Clinical Trials><Collaborations><Communities><Computers><Data><Development><Device Approval><Device Approval Process><Device Designs><Device Safety><Devices><Diagnosis><Diagnostic><Disease><Disorder><Dropsy><Drug resistance><Edema><Effectiveness><Electrocorticogram><Electrodes><Encephalon><Engineering><Epilepsy><Epileptic Seizures><Epileptics><Excision><Extirpation><FDA approved><Face><Failure><Film><Focal Epilepsy><Focal Seizure Disorder><Freedom><Frequencies><Future><Hemorrhage><Human><Hydrops><Implant><Individual><Industrialization><Inflammation><Infrastructure><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Intractable Epilepsy><Leanness><Length of Stay><Liberty><Localization-Related Epilepsy><Location><Marketing><Measurement><Measures><Medical><Microelectrodes><Miniaturized Electrodes><Modern Man><Modernization><Monitor><Morbidity><Morbidity - disease rate><Morphologic artifacts><Multi-Institutional Clinical Trial><Multi-center clinical trial><Multi-site clinical trial><Multicenter clinical trial><Multisite clinical trial><Neocortex><Nerve Impulse Transmission><Nerve Transmission><Nervous System Diseases><Nervous System Disorder><Neurologic><Neurologic Disorders><Neurological><Neurological Disorders><Neurological Surgery><Neuronal Transmission><Neurosurgical Procedures><New York><Noise><Notification><Number of Days in Hospital><Operative Procedures><Operative Surgical Procedures><Outcome><Pain><Painful><Partial Epilepsies><Partial Seizure Disorder><Patients><Pattern><Performance><Personalized medical approach><Phase><Play><Preclinical Testing><Randomized><Records><Refractory epilepsy><Removal><Resistance><Resolution><Risk><Rodent><Rodentia><Rodents Mammals><Role><Safety><Sales><Sampling><Scientific Advances and Accomplishments><Scientist><Seizure Disorder><Seizures><Signal Transduction><Signal Transduction Systems><Signaling><Site><Statistical Data Analyses><Statistical Data Analysis><Statistical Data Interpretation><Sterilization><Surgical><Surgical Interventions><Surgical Procedure><Surgical Removal><Survey Instrument><Surveys><Swelling><System><Technology><Testing><Therapeutic><Thick><Thickness><Thinness><Tissues><Translating><Universities><Utah><Vectra><Work><axon signaling><axon-glial signaling><axonal signaling><biocompatibility><biological signal transduction><biomaterial compatibility><biomedical implant><blood loss><clinical test><clinical trial enrollment><computerized data processing><cost><data acquisition><data acquisitions><data processing><data visualization><density><developmental><diagnostic ability><diagnostic capability><diagnostic power><diagnostic utility><diagnostic value><drug resistant><drug-resistant epilepsy><electrocorticography><epilepsia><epileptogenic><faces><facial><flexibility><flexible><glia signaling><glial signaling><homotypical cortex><hospital days><hospital length of stay><hospital stay><implant device><implantable device><implantation><improved><individualized approach><indwelling device><interest><interventional strategy><isocortex><large scale data><large scale data sets><large scale datasets><liquid crystal polymer><manufacture><medical college><medical schools><meter><microstimulation><microsystems><miniaturize><miniaturized><model of animal><mortality><neocortical><neopallium><nerve signaling><neural><neural inflammation><neural signaling><neuroinflammation><neuroinflammatory><neurological disease><neuronal signaling><neurotransmission><next generation><non-human primate><nonhuman primate><novel><patient safety><patient tolerability><patient tolerance><personalization of treatment><personalized approach><personalized medicine><personalized therapy><personalized treatment><pre-clinical testing><precision approach><prototype><randomisation><randomization><randomly assigned><research clinical testing><resection><resistance to Drug><resistant><resistant to Drug><resolutions><retina implantation><retinal implant><school of medicine><scientific accomplishments><scientific advances><social role><standard of care><statistical analysis><success><surgery><tailored approach>