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Intracranial multimodal physiological monitoring in acute brain injury

Award Number: UG3NS123307
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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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 which 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 requiring 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 with a target diameter which is equivalent to, or smaller than, individual current probes. 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) and transmit these sensor signals to monitors as a time- locked single digital data stream. We will develop a display unit called the NeuroMonitor to analyze and display the acquired multimodal data in a synchronized real-time manner. We call the composite solution created by the NeuroProbe, NeuroLink, and NeuroMonitor devices 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	3/21/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $2,292,640 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	8/1/2024	NON-COMPETING CONTINUATION	$0
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	7/26/2024	NON-COMPETING CONTINUATION	$1,603,729
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	3	8/15/2024	SUPPLEMENT FOR EXPANSION	$688,911
														Subtotal = $2,292,640

Issue Date FY: 2023 ( Subtotal = $1,658,095 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	2	9/5/2023	NON-COMPETING CONTINUATION	$1,658,095
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	2/9/2023	NEW	$0
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	6/8/2023	NEW	$0
														Subtotal = $1,658,095

Issue Date FY: 2022 ( Subtotal = $1,697,634 )
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/2/2022	NEW	$1,697,634
														Subtotal = $1,697,634

Grand Total All Awards = $5,648,369

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Intracranial multimodal physiological monitoring in acute brain injury

Award Number: UG3NS123307

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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