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An Implantable Wireless System to Study Gastric Neurophysiology

Award Number: U18EB021789
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)
PERIOD OF PERFORMANCE START DATE: 09/15/2018
PERIOD OF PERFORMANCE END DATE: 07/31/2019

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An Implantable Wireless System to Study Gastric Neurophysiology - DESCRIPTION (provided by applicant): Gastric contractions are initiated and coordinated by an underlying bioelectrical activity termed slow waves (SWs). Aberrant SW patterns (dysrhythmias) have been associated with gastric dysmotility in several significant gastric disorders, notably gastroparesis (GP) and functional dyspepsia. There are also well- documented associations between GP and damage to the vagus nerve that are common in people with diabetes. Gastric pacing and vagus nerve stimulation have been proposed as treatment modalities for gastric dysrhythmia. However, the pathophysiological roles of electrical dysrhythmias and neural mechanisms in gastric motility disorders, and the role and therapeutic potential of the vagus and gastric electrical stimulation remain weakly defined. This is mainly due to the lack of technologies that can reveal the mechanisms of action. Electroneurogram (ENG) signals obtained through cuff electrodes from the peripheral nerves have been shown to provide valuable information regarding operation of afferent and efferent nerves. Compared to microelectrodes, cuff electrodes are minimally invasive and provide stable recordings long-term. These signals have been used to study neuromuscular, cardiovascular, gastrointestinal, sympathetic and parasympathetic systems. The ENG signal is most informative when it can be associated with the function of the end organ. When studying conscious freely-behaving subjects, this requires implantable devices that can simultaneously acquire ENG and associated organ functions. To fully understand the underlying mechanisms of action of gastric pacing and neuromodulation therapies for functional motility disorders, a tool that can map and monitor-in high resolution-the coordinated activity of gastric SWs and ENG signals from peripheral nerves such as vagal branches innervating the stomach in real time would be invaluable. Gastric SWs directly recorded from the stomach serosa provide the only reliable and descriptive source of data on spatial dysrhythmic patterns. However, a key limitation is that wires traverse the abdominal wall or a natural orifice, posing risks of discomfort, dislodgement, or infection. We propose to develop and validate, in a porcine model, a Wireless Implantable Neuro- Gastroenterology System (WINGS) that can simultaneously acquire SWs and compound action potentials from the gastric peripheral nerves and map these signals in high resolution. The system consists of an implantable system-on-chip to condition and wirelessly transmit the signals, a wearable unit to wirelessly recharge the implant and relay the signals, and a receiver connected to a computer to display, store, and process the data. With its dual capability to monitor ENGs and SWs, WINGS can be implanted laparoscopically or endoscopically via a single minimally invasive procedure. Because the two types of signals will be acquired by one device, their precise timing will be known, and no synchronization will be required.


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: 2021 ( Subtotal = -$1,693 )
2021	2018	NEW YORK INSTITUTE OF TECHNOLOGY	NORTHERN BLVD	OLD WESTBURY	NY	11568	NASSAU	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	6/23/2021	SUPPLEMENT FOR EXPANSION	-$1,693
														Subtotal = -$1,693

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2016	NEW YORK INSTITUTE OF TECHNOLOGY INC	NORTHERN BLVD	OLD WESTBURY	NY	11568	NASSAU	USA	Trans-NIH Research Support	000	2	2/22/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $116,604 )
2018	2018	NEW YORK INSTITUTE OF TECHNOLOGY INC	NORTHERN BLVD	OLD WESTBURY	NY	11568	NASSAU	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	9/14/2018	SUPPLEMENT FOR EXPANSION	$116,604
2018	2018	NEW YORK INSTITUTE OF TECHNOLOGY INC	NORTHERN BLVD	OLD WESTBURY	NY	11568	NASSAU	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	002	2	9/28/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2016	NEW YORK INSTITUTE OF TECHNOLOGY INC	NORTHERN BLVD	OLD WESTBURY	NY	11568	NASSAU	USA	Trans-NIH Research Support	000	2	8/22/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $116,604

Issue Date FY: 2017 ( Subtotal = $142,200 )
2017	2017	NEW YORK INSTITUTE OF TECHNOLOGY INC	NORTHERN BLVD	OLD WESTBURY	NY	11568	NASSAU	USA	Trans-NIH Research Support	000	2	8/3/2017	SUPPLEMENT FOR EXPANSION	$142,200
														Subtotal = $142,200

Issue Date FY: 2016 ( Subtotal = $328,909 )
2016	2016	NEW YORK INSTITUTE OF TECHNOLOGY	NORTHERN BOULEVARD	OLD WESTBURY	NY	11568	NASSAU	USA	Trans-NIH Research Support	000	2	9/2/2016	NON-COMPETING CONTINUATION	$231,568
2016	2016	NEW YORK INSTITUTE OF TECHNOLOGY	NORTHERN BOULEVARD	OLD WESTBURY	NY	11568	NASSAU	USA	Trans-NIH Research Support	001	2	9/19/2016	SUPPLEMENT FOR EXPANSION	$97,341
														Subtotal = $328,909

Issue Date FY: 2015 ( Subtotal = $225,622 )
2015	2015	NEW YORK INSTITUTE OF TECHNOLOGY	NORTHERN BOULEVARD	OLD WESTBURY	NY	11568	NASSAU	USA	Trans-NIH Research Support	000	1	9/25/2015	NEW	$225,622
														Subtotal = $225,622

Grand Total All Awards = $811,642

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An Implantable Wireless System to Study Gastric Neurophysiology

Award Number: U18EB021789

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

PERIOD OF PERFORMANCE START DATE: 09/15/2018

PERIOD OF PERFORMANCE END DATE: 07/31/2019

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