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Wearable sensors for quantitative assessment of motor impairment in Huntington's disease
Investigator (PI): Gwin, Joseph T
Performing Organization (PO): (Current): BioSensics / (888) 589-6213
Supporting Agency (SA): National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Initial Year: 2017
Final Year: 2019
Record Source/Award ID: RePorter/R44NS103648
Funding: 2017 Award Amount: $1,314,945
2018 Award Amount: $1,207,381
Award Type: Grant
Abstract: The principal means of measuring motor impairment in Huntington's 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, and 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 Small Business Innovation Research grant (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 wearable 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 one 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.
MeSH Terms:
  • Activities of Daily Living
  • Algorithms
  • Chorea /*diagnosis
  • Computer Simulation
  • Gait
  • Gait Disorders, Neurologic /*diagnosis
  • Humans
  • Huntington Disease /*diagnosis
  • Monitoring, Ambulatory /*instrumentation
  • /*methods
  • Motor Skills Disorders /*diagnosis
  • Pilot Projects
  • Public Health
  • Severity of Illness Index
  • Telemedicine /methods
  • Wearable Electronic Devices
  • Wrist
Keywords:
  • Huntington disease
  • Small Business Innovation Research grant
  • algorithms
  • chorea
  • clinical research
  • gait
  • measures
  • motor impairment
  • movement disorders
  • pharmaceutical preparations
  • pharmacologic substance
  • sensor
  • technology
  • telehealth
  • telehealth systems
  • wrist
Country: United States
State: Massachusetts
Zip Code: 02472
UI: 20184090
Project Status: Completed