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An integrated electrical impedance myography platform for neuromuscular disease classification and diagnosis

Award Number: R44NS113756
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2017
PERIOD OF PERFORMANCE END DATE: 07/31/2023

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An integrated electrical impedance myography platform for neuromuscular disease classification and diagnosis - Project Summary Improved methods for the bedside diagnosis and evaluation of neuromuscular disorders are needed. One technology that is finding increasing use for this purpose is electrical impedance myography (EIM). In EIM, a very weak, high frequency electrical current is passed through a muscle of interest and the resulting surface voltages are measured. Disease associated alterations in the composition and microstructural features of the muscle produce characteristic changes that can be used to help classify specific conditions and grade disease severity. To date, most studies using EIM analysis have utilized a fairly limited data set for disease assessment. While effective, this approach ignores a great deal of information locked within the impedance data, including those values that can assist in predicting specific muscle features (such as myofiber diameter) and the presence of pathological change (e.g., fat or connective tissue deposition). In addition, as it stands, the data set is challenging for the clinician to understand without a detailed knowledge of impedance theory. Myolex, Inc is a small business concern located in Boston, MA has as its main focus the development of EIM technologies for clinical use. Myolex recently completed a Phase 1 SBIR that demonstrated the potential capability of machine learning based classification algorithms to effectively discriminate healthy muscle from diseased and to discriminate one disease from another. In this proposed work, we will greatly advance this concept by embodying classification algorithms into a powerful new software suite for Myolex’s current EIM system, the mView. Our underlying hypothesis is that EIM data analysis can be automated to the point that classification systems can provide data on disease diagnosis as well as disease severity for improved ease-of-use. We propose to study this hypothesis via 2 specific aims. In Specific Aim 1, we will design a software suite capable of assisting with artifact-free data collection to be incorporated into our current EIM system, the mViewTM. Then using classification paradigms based on a prodigious amount of previous collected data, we will develop an automated data analysis tool to help provide data on disease category as well as microscopic features, muscle based on the impedance data alone using Microsoft’s Azure Cloud platform. In Specific Aim 2, we will test this developed software suite in a total of180 adult and pediatric neuromuscular disease patients and healthy participants evaluated at Ohio State University Wexner Medical Center (adults) and Boston Children’s Hospital (children). During this data collection period, the Ohio State and Boston Children’s researchers will have real- time access to Myolex staff to provide feedback and have questions/problems answered and addressed. The user interface will continue to be refined and classification algorithms improved. At the conclusion of this work, a new diagnostic tool will be developed for potential 510(k) FDA approval. It will serve as the basis for a continuously self-refining system as additional data sets are collected by end-users employing them in regular clinical use.


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: 2024 ( Subtotal = $0 )
2024	2020	MYOLEX, INC.	1309 BEACON ST STE 300	BROOKLINE	MA	02446	NORFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	3/6/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	MYOLEX INC	1309 BEACON ST STE 300	BROOKLINE	MA	02446	NORFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	7/28/2022	NON-COMPETING CONTINUATION	$0
2022	2020	MYOLEX INC	1309 BEACON ST STE 300	BROOKLINE	MA	02446	NORFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	11/8/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	MYOLEX INC	1309 BEACON ST STE 300	BROOKLINE	MA	02446	NORFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	12/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $869,698 )
2020	2020	MYOLEX INC	1309 BEACON ST STE 300	BROOKLINE	MA	02446	NORFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/6/2020	NON-COMPETING CONTINUATION	$869,698
														Subtotal = $869,698

Issue Date FY: 2019 ( Subtotal = $621,318 )
2019	2019	MYOLEX INC	1309 BEACON ST STE 300	BROOKLINE	MA	02446	NORFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/26/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$621,318
														Subtotal = $621,318

Grand Total All Awards = $1,491,016

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An integrated electrical impedance myography platform for neuromuscular disease classification and diagnosis

Award Number: R44NS113756

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/20/2017

PERIOD OF PERFORMANCE END DATE: 07/31/2023

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