Comprehensive assessment of the safety and efficacy of peripheral nerve implant technologies for neuroprosthetic and neuromodulation applications.
We investigate the electrode/tissue interface, using chronic in vivo electrophysiology to assess device performance, immunohistochemistry and advanced tissue processing technology (CLARITY) to evaluate neural structure and neuroinflammation, longitudinal in vivo imaging to look at structural dynamics of neurons and vasculature, and in vitro assays to detect changes to electrode materials properties.
We use high intensity focused ultrasound to induce mild traumatic brain injury (mTBI) in mouse, histological and behavioral testing to evaluate structural damage and functional deficit following mTBI, and in vivo electrophysiology and imaging techniques to detect mTBI. We investigate the use of novel EEG electrodes for the detection of mTBI.
Medical devices that interface directly with the nervous system are emerging as essential therapeutic and diagnostic modalities for conditions including paralysis, amputation, Parkinson’s disease, epilepsy, traumatic brain injury, rheumatoid arthritis, and blindness. Novel neurological devices, such as those under development in the BRAIN initiative, NIH SPARC, and the DARPA Biological Technologies Office, have the potential to expand the impact of device interventions to improve patient health. Using cutting-edge research methodology and state-of-the-art technology, our laboratory investigates the safety and reliability of neurological devices applicable to the central and peripheral nervous systems. Investment in regulatory science involving innovative medical device technologies advances science-based regulatory review at the FDA to ensure patients have expedited access to safe and effective neurological devices.
Central Nervous System Research led by Meijun Ye, PhD and Krystyna Solarana, PhD
- Assessment of the long-term reliability of implanted electrodes
- Characterization of acute and long-term neural tissue and functional responses to implanted passive and active neural devices
- Evaluation of long-term safety and reliability of optogenetics
- Investigation of emerging technologies for the diagnosis of mild traumatic brain injury in rodent models
- Translating novel non-invasive diagnostic biomarkers of mild traumatic brain injury to a patient population
Peripheral Nervous System Research led by Srikanth Vasudevan, PhD
- Development of test platforms to assess chronic safety and performance of peripheral nerve interfaces
- Evaluation of the safety and efficacy of ultrasound for neuromodulation
- Assessment of novel ultrasound powered implants for power transfer and telemetry
- Identification of biological sex differences in the safety of autonomic neuromodulation
- Development of predictive imaging biomarkers for electrical stimulation induced nerve injury
Office of the Chief Scientist Challenge Grant
Daniel X. Hammer. Ph.D.
Krystyna Solarana, Ph.D.
Srikanth Vasudevan, Ph.D.
Meijun Ye, Ph.D.
Eugene F. Civillico, Ph.D.
Hyounguk Jang, Ph.D.
Kee Jang, Ph.D.
Guillermo Monroy, Ph.D.
Nicolas Vivaldi, Ph.D.
Elissa Wong, Ph.D.
Farid Yaghouby, Ph.D.
Luann McKinney, Ph.D.
Leslie McKinney, Ph.D.
Matthew Myers, Ph.D.
Shyama Patel, Ph.D.
Joshua Pfefer, Ph.D.
Jakob Reister, Ph.D.
Larry Schmued, Ph.D
Christopher Scully, Ph.D.
Pavel Takmakov, Ph.D.
Christopher Toscano, Ph.D.
Lin Xu , M.D., Ph.D.
University of California, San Diego
University of Utah
Massachusetts General Hospital
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
New York Medical College
University of Colorado Denver
Neurological Devices Laboratory
- State-of-the-art small animal surgical suite
- Broadband impedance measurement system
- Electrophysiological recording, stimulation and analysis system
- Video based behavioral assessment systems
- Two-photon microscope
- Optical coherence tomography
- Olympus confocal microscope
- Wireless physiological monitoring system
Relevant standards & guidances
Selected peer-review publications
- Jang et al., Alterations in neurovascular coupling following acute traumatic brain injury. Neurophotonics. 2017
- Huang et al., Epidermal electrode technology for detecting ultrasonic perturbation of sensory brain activity. IEEE Trans Biomed Eng. 2018
- Vasudevan et al., Rodent model for assessing the long term safety and performance of peripheral nerve recording electrodes. J. Neural Eng. 14, 016008 (2017)
- Bowsher et al., Brain–computer interface devices for patients with paralysis and amputation: a meeting report. J. Neural Eng. 13, 023001 (2016).
- Fisher et al., Real-Time Detection and Monitoring of Acute Brain Injury Utilizing Evoked Electroencephalographic Potentials, IEEE Trans Neural Syst Rehabil Eng. 2016
- Lozzi et al., Image quality metrics for optical coherence angiography, Biomed Opt Express. 2015
- Takmakov et al., Rapid evaluation of the durability of cortical neural implants using accelerated aging with reactive oxygen species, Journal of Neural Engineering. 2015. Featured article.
- Hammer et al., Longitudinal vascular dynamics following cranial window and electrode implantation measured with speckle variance optical coherence angiography. Biomedical Optics Express, 2014. Featured in Optical Coherence Tomography News.
- Welle and Krauthamer, FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators, IEEE Engineering in Medicine and Biology, Pulse Magazine 2012.