Next-Generation Wireless Intracranial Electrode Arrays for Post-Traumatic Epilepsy
Abstract
Background: Traumatic brain injury (TBI) is widespread, with approximately 2.8 million TBI-related emergency department visits, 282,000 TBI-related hospitalizations, and 56,000 TBI-related deaths in the U.S. in 2013 alone. TBI is more common among Veterans compared to the general population. A significant consequence of TBI is post-traumatic epilepsy (PTE), defined as the occurrence of two or more unprovoked seizures 7 days or more after injury. PTE develops as a consequence of epileptogenesis, a process whereby a non-epileptic brain undergoes changes that can lead to seizures. However, the underlying neural signals during epileptogenesis following brain injury are unknown due to technical limitations in brain recordings. Patients with severe TBI associated with cerebral contusion and intracerebral hemorrhage are up to 43× more likely to develop epilepsy than the general population. The latent period between TBI and the first clinical seizure can be a year or longer, making it difficult to predict if and when epilepsy will develop. This can lead to both over and under treatment of patients during the latent period when we are unable to accurately predict who will develop PTE due to limitations in our ability to monitor patients effectively over long durations. Objective: We propose to develop a new generation of wireless implantable electrode arrays to provide high-density, long-term recordings of seizure networks, outside the hospital, in order to predict epileptogenesis in patients with TBI and provide better monitoring for epilepsy. Our technology will also guide more effective medical management and surgical treatment of epilepsy by providing vastly more detailed data to clinicians planning patient care. Our objective is to design and perform first-in-human studies of fully implantable wireless electrode arrays that will replace the current standard of care wired electrodes that have been used for the past 40+ years. Our electrode arrays would be implantable in TBI patients post-injury, who are at an increased likelihood of developing epilepsy. This would enable unprecedented access to human electrophysiological data during the latent period of epileptogenesis, thereby enabling a better understanding of how PTE develops. To enable this ability, we will develop tools that allow for wireless high density recordings of human brains over long periods of time. Specific Aims and Research Strategy: SA1: Integrate wireless recording system with thin-film electrode arrays. We will integrate our wireless technology, which supports recording and stimulating thousands of electrodes, with high-density liquid crystal polymer electrode arrays. Wireless arrays will be tested for reliability and biocompatibility. SA2: Implant wireless arrays in non-human primates (NHPs) to evaluate long-term recording capabilities. After wireless arrays have been successfully tested in vitro, they will be implanted in NHPs. We will collect continuous wireless recordings from NHPs performing behavioral tasks. We will also demonstrate stable, long-term recording of neural signals to test the reliability of the wireless devices. SA3: Test wireless arrays intra-operatively in humans. To demonstrate the ability of our wireless arrays to capture clinically relevant, micro- and macro-scale electrographic signals, we will perform intra-operative recordings using our wireless arrays in epilepsy patients undergoing resective surgery. Innovation and Impact: By developing high-density, high-channel-count wireless electrode arrays, it will finally be possible to study epileptogenesis in humans following TBI. The data collected from these patients will not only be the first of its kind for PTE, but also present the opportunity to study how seizure networks develop. Our >25× increase in sampling resolution will also allow for better seizure network localization if epilepsy develops, and provide higher quality data for surgical resection. Our wireless ar
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110538
Entities
People
- Jonathan Viventi
Organizations
- Duke University
- United States Army