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FitMi VNS: The First Automated Home Therapy System for Exercise-Paired Vagus Nerve Stimulation After Stroke

Award Number: U44NS117306
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: 06/01/2021
PERIOD OF PERFORMANCE END DATE: 05/31/2024

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FitMi VNS: The First Automated Home Therapy System for Exercise-Paired Vagus Nerve Stimulation After Stroke - It is estimated that 1 in 6 people worldwide will experience a stroke, with 50-70% experiencing chronic movement impairment. While intensive motor training can partially restore motor function in these individuals, the improvement is often incomplete, as the physiological processes driving recovery through motor training alone are insufficient to fully restore function. Vagus Nerve Stimulation (VNS) paired with motor training has recently emerged as a promising method to improve movement recovery by increasing neuroplasticity through targeted release of neurotransmitters. In a recent pilot study with individuals with chronic stroke, Kimberley et al. found large, clinically significant improvements in upper extremity movement ability following an intervention of manually-triggered exercise-paired VNS compared to control, also confirming that it was safe to deliver this stimulation at home. However, a manually triggered VNS system has critical limitations. First, motor recovery is sensitive to stimulation timing but it is impractical to optimize stimulation timing with a manually-triggered system in the clinic, and impossible to do so at home. Second, operating a manually triggered system distracts therapists from optimally supporting patients during therapy. An automated, closed-loop VNS delivery system could improve both the practicality and therapeutic effects of exercise-paired VNS. Thus, for this Direct-to-Phase II SBIR, we propose to complete development of a robust, FDA compliant, automatically triggered exercise-paired VNS system called FitMi VNS system and to test the safety and usability of this system in the clinic and at home in an exploratory clinical trial with individuals with chronic stroke. Our specific aims for this Phase II project are to: Aim 1) Complete an integrated FitMi VNS software system to mitigate potential risks and develop a HIPAA compliant remote monitoring platform; Aim 2) Complete bench-top verification and validation testing and supervised, in-vivo safety testing of FitMi VNS in individuals with chronic stroke (n = 10). Here, our goal is for >99% of stimulations to be delivered with optimal timing and no adverse events or safety-related issues; and Aim 3) Complete an at-home safety and feasibility study of FitMi VNS in individuals with chronic stroke (n = 20). Our hypothesis is that FitMi VNS will safely provide closed-loop, exercise-paired VNS both in the clinic and at home. We will evaluate the therapeutic benefit of FitiMi VNS in a large scale randomized controlled efficacy study in Phase III. At the end of this project, we will have rigorously refined the FitMi VNS system and performed initial safety and feasibility testing in the clinic and at home. If successful, FitMi VNS will be the first system to provide automated, closed-loop exercise- paired VNS for stroke rehabilitation, leading to a step change in motor recovery for individuals with stroke.


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	2022	FLINT REHABILITATION DEVICES, LLC	18023 SKY PARK CIR STE H2	IRVINE	CA	92614	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	10/17/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $845,369 )
2022	2022	FLINT REHABILITATION DEVICES, LLC	18023 SKY PARK CIR STE H2	IRVINE	CA	92614	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	6/2/2022	NON-COMPETING CONTINUATION	$845,369
														Subtotal = $845,369

Issue Date FY: 2021 ( Subtotal = $667,003 )
2021	2021	FLINT REHABILITATION DEVICES, LLC	18023 SKY PARK CIR STE H2	IRVINE	CA	92614	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	6/15/2021	NEW	$0
2021	2021	FLINT REHABILITATION DEVICES, LLC	18023 SKY PARK CIR STE H2	IRVINE	CA	92614	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	5/28/2021	NEW	$667,003
														Subtotal = $667,003

Grand Total All Awards = $1,512,372

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FitMi VNS: The First Automated Home Therapy System for Exercise-Paired Vagus Nerve Stimulation After Stroke

Award Number: U44NS117306

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: 06/01/2021

PERIOD OF PERFORMANCE END DATE: 05/31/2024

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