Project Details
Description
PROJECT SUMMARY
WINCS International LLC, in partnership with Mayo Clinic, proposes to develop and demonstrate a highly
innovative next-generation clinical instrument together with custom user-friendly display and analysis software.
For the first time, the Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation
(MAVEN) will offer wireless voltammetric sensing of multiple neurotransmitters (e.g., dopamine, serotonin, and
adenosine) at carbon-fiber microelectrodes. MAVEN can be applied to a broad range of clinical neuroscience
research subjects involving brain neurosurgeries. Alongside these multiple neurochemical sensing capabilities,
the device will be capable of near-simultaneous electrophysiological (e.g., action and local field potentials)
recordings. The main innovation of the MAVEN system is to include state-of-the-art voltammetric techniques to
quantitatively measure both phasic (stimulation-induced) and tonic (resting) concentration levels of
neurochemicals in real-time and near-simultaneously with other recording modalities. This capability is
currently unavailable in clinical neuroscience research. In addition, multiple cyclic square wave voltammetry
(MCSWV) will enable second-to-second quantitative measurements of tonic extracellular levels of dopamine
and serotonin with exceptional spatial resolution, sensitivity, specificity, and minimal tissue disturbance. This
proposal employs our unique combined expertise in neuroscience, electrochemistry, engineering, and software
development to validate this novel clinical research instrument in preparation for its use during intraoperative
clinical neurosurgeries. Also, combining electrophysiology and electrochemical technologies would enable
investigators to probe unexplored links between the abnormal activity of neural elements and the
dopaminergic, serotonergic, purinergic (adenosine) dynamics associated with neuropsychopathologies, such
as Parkinson’s disease, essential tremor, obsessive-compulsive disorder, depression, and epilepsy. Our large
animal model (swine) studies emulating existing human intraoperative neurosurgical procedures will provide
essential information to guide and inform the finalization of the MAVEN design for use by the clinical
neuroscience community in future IDE-enabled mechanistic clinical studies.
Our proposal seeks to (1) finalize the development of MAVEN, together with a sophisticated user-friendly
software interface that (2) meets device manufacturing processes, regulatory Design Control, and medical
safety requirements to obtain an FDA-approved Investigational Device Exemption (IDE), and (3) use a swine
model to develop MAVEN stimulation and recording protocols for use in existing intraoperative neurosurgical
procedures (e.g., deep brain stimulation neurosurgeries and cortical lobectomies). This includes demonstrating
the functionality, versatility, and efficacy of the MAVEN system for future pre-clinical and clinical neuroscience
research.
Status | Active |
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Effective start/end date | 9/12/22 → 8/31/24 |
Funding
- National Institute of Neurological Disorders and Stroke: $438,792.00
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