UG3NS123307

Intracranial Multimodal Physiological Monitoring in Acute Brain Injury - Project Summary

Present day multimodal monitoring for traumatic brain injury (TBI) is limited in its implementation as it necessitates multiple invasive probes to measure intracranial pressure (ICP), intracranial EEG (ICEEG), intracranial temperature (ICT), and brain tissue oxygen (PBTO2). The majority of these probes require their own instrumentation and monitors. While there is increasing evidence to support multimodal monitoring in TBI and other acute brain injuries, the present cumbersome systems make it nearly impossible to use outside of major level 1 trauma centers.

The challenges include the need for expertise with both probe placement and data interpretation, as well as the integration of multiple electronic units from different vendors with diverse software systems. Each of these units requires training, IT, and biomedical engineering support. Coupled with this is an increased risk of bleeding and infection from the multiple entry points into brain parenchyma.

Our objective is to develop a single source brain monitoring solution for the management of severe TBI. We will integrate the modalities indicated for severe TBI (ICP, ICEEG, ICT, PBTO2) in a brain implantable device called the NeuroProbe. This device will have a target diameter that is equivalent to, or smaller than, individual current probes.

Additionally, we will develop a single interface device called the NeuroLink to acquire the multi-modal intracranial data from the NeuroProbe, as well as scalp EEG and patient physiological data including systemic blood pressure (SBP), heart rate (HR), mean arterial pressure (MAP), and blood oxygen (SPO2). These sensor signals will be transmitted to monitors as a time-locked single digital data stream.

To analyze and display the acquired multimodal data in a synchronized real-time manner, we will develop a display unit called the NeuroMonitor. The composite solution created by the NeuroProbe, NeuroLink, and NeuroMonitor devices will be referred to as the NeuroProbe Solution.

The technological development of the NeuroProbe Solution dramatically expands the capabilities of the existing ICEEG depth electrodes developed at Yale University and multimodal probes currently on the market. The key innovations of the NeuroProbe Solution are:

1. Integration of multiple physiologic sensors on a single intracranial probe (NeuroProbe).
2. Simplification of NeuroProbe to allow placement at bedside in a civilian or military facility.
3. Development of a multimodal interface device (NeuroLink) to store and relay time-locked digital data acquired from the NeuroProbe and extracranial sensors to the NeuroMonitor and other clinical monitors.
4. Development of an iPad-sized monitor (NeuroMonitor) to analyze and display multimodal data.
5. Time-locked multi-stream data transfer which allows for real-time and post-hoc data review and analysis.

This innovative solution allows acquisition and integration of data from multiple physiological parameters through a standard small tablet, creating a simple single end-to-end solution from sensors to multimodal data analysis and display in an otherwise fragmented and complex domain.

Yale Univ

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Connecticut United States

State-Wide

Translational Neural Devices (UG3/UH3 - Clinical Trial Required) (RFA-NS-18-011)

Amendment Since initial award the End Date has been extended from 07/31/25 to 07/31/26 and the total obligations have increased 233% from $1,697,634 to $5,648,369.