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Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease

Award Number: R44NS103648
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: 09/01/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2021

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Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease - ABSTRACT The principal means of measuring motor impairment in Huntington disease (HD) is the Unified Huntington's Disease Rating Scale (UHDRS) total motor score, which is subjective and categorical. Wearable sensors could enable objective, sensitive, continuous assessment of motor impairments in individuals with a variety of neurological movement disorders. This is important because large amounts of objective data acquired at a high frequency in a real-world setting could reduce the time and cost of early stage clinical trials. Clinically, wearable sensors for motor assessment during activities of daily living could be used to expedite and improve medication titration. In HD, wearable sensors that could detect subtle motor abnormalities in the premanifest phase of the disease would be valuable for monitoring early therapeutic intervention trials and could provide insight into the phase of clinical disease onset. We have recently completed a series of pilot studies (1 published article and 1 manuscript in preparation) supported by Auspex Pharmaceuticals (now part of Teva Pharmaceuticals) demonstrating that a wearable sensor on the torso can detect gait related motor impairments in HD and a wearable sensor on the wrist can identify the occurrence and severity of upper extremity chorea. In this Direct to Phase II SBIR we propose to build upon this Phase I equivalent pilot work by developing a telehealth system for continuous remote assessment of Huntington's chorea using wearable sensors. Based on our pilot research we propose to develop a system consisting of two wearables sensors to be worn on the dominant wrist and on the torso. In partnership with the University of Rochester, we will conduct a clinical study to improve and further validate algorithms for detecting chorea severity, and to evaluate whether sensor-derived measures can detect pharmacological response to anti-chorea medication or subtle motor abnormalities in the premanifest stage of HD. Participants will visit the clinic at baseline and then once a quarter for a total of 5 visits. Assessments will include the motor portion of the UHDRS, Q-motor assessment, a Timed-Up-and-Go walking test, and a series of simulated activities of daily living. This assessment will be conducted twice, on- and off-medication. Participants will wear the two sensors during in-clinic assessments and for a period of 1-week thereafter. There is a significant commercialization potential for the proposed technology. This includes pharmaceutical clinical trials, where the promise of wearable sensors has led to significant investment in the development of technologies for Parkinson's disease. However, the smaller patient population of individuals with Huntington's disease has been completely overlooked. This represents both a significant public health need and market opportunity for BioSensics. Teva Pharmaceuticals, who provided the financial support for our Phase I equivalent pilot work, and the Huntington's Disease Society of America have expressed an interest in the proposed technology and are supportive of our efforts (see Letters of Support).


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	2018	BIOSENSICS LLC	57 CHAPEL ST STE 200	NEWTON	MA	02458	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	4/26/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	BIOSENSICS LLC	57 CHAPEL ST STE 200	NEWTON	MA	02458	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/25/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,207,381 )
2018	2018	BIOSENSICS LLC	42 PLEASANT STREET, SUITE 2	WATERTOWN	MA	02472	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/20/2018	NON-COMPETING CONTINUATION	$1,207,381
														Subtotal = $1,207,381

Issue Date FY: 2017 ( Subtotal = $1,314,945 )
2017	2017	BIOSENSICS LLC	42 PLEASANT STREET, SUITE 2	WATERTOWN	MA	02472	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/24/2017	NEW	$1,314,945
														Subtotal = $1,314,945

Grand Total All Awards = $2,522,326

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Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease

Award Number: R44NS103648

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: 09/01/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2021

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