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

利用灵活的高分辨率薄膜电极推进癫痫诊断

• 批准号: 10753771
• 负责人: Robert Kyle Franklin
• 金额: $ 14万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10753771
• 关键词: Administrative Supplement; Advanced Development; American; Animal Model; Area; Biology; Clinical Trials; Collaborations; Data; Development; Device Designs; Devices; Diagnosis; Diagnostic; Effectiveness; Electrodes; Engineering; Epilepsy; FDA approved; Face; Failure; Film; Freedom; Funding; Future; Grant; Implant; Individual; Industrialization; Intractable Epilepsy; Location; Modernization; Neocortex; Neurologic; Neurosurgical Procedures; New York; Operative Surgical Procedures; Pain; Parents; Partial Epilepsies; Phase; Play; Preclinical Testing; Randomized; Resolution; Risk; Role; Sampling; Scientist; Seizures; Site; Source; Swelling; System; Technology; Testing; Thinness; Tissues; Translating; United States National Institutes of Health; Universities; Utah; Work; cost; data acquisition; diagnostic value; flexibility; implantation; improved; large scale data; liquid crystal polymer; medical schools; microsystems; neocortical; nervous system disorder; neural; neuroinflammation; next generation; nonhuman primate; novel; patient tolerability; personalized approach; personalized medicine; prototype; research clinical testing

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

项目总结