BIOSENSICS LLC — Department of Health and Human Services SBIR Phase II: 106

Description

ABSTRACT The principal means of measuring motor impairment in Huntington diseaseHDis the Unified Huntington s Disease Rating ScaleUHDRStotal motor scorewhich is subjective and categoricalWearable sensors could enable objectivesensitivecontinuous assessment of motor impairments in individuals with a variety of neurological movement disordersThis 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 trialsClinicallywearable sensors for motor assessment during activities of daily living could be used to expedite and improve medication titrationIn HDwearable 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 onsetWe have recently completed a series of pilot studiespublished article andmanuscript in preparationsupported by Auspex Pharmaceuticalsnow part of Teva Pharmaceuticalsdemonstrating 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 choreaIn 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 sensorsBased 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 torsoIn partnership with the University of Rochesterwe will conduct a clinical study to improve and further validate algorithms for detecting chorea severityand to evaluate whether sensor derived measures can detect pharmacological response to anti chorea medication or subtle motor abnormalities in the premanifest stage of HDParticipants will visit the clinic at baseline and then once a quarter for a total ofvisitsAssessments will include the motor portion of the UHDRSQ motor assessmenta Timed Up and Go walking testand a series of simulated activities of daily livingThis assessment will be conducted twiceonand off medicationParticipants will wear the two sensors during in clinic assessments and for a period ofweek thereafterThere is a significant commercialization potential for the proposed technologyThis includes pharmaceutical clinical trialswhere the promise of wearable sensors has led to significant investment in the development of technologies for Parkinson s diseaseHoweverthe smaller patient population of individuals with Huntington s disease has been completely overlookedThis represents both a significant public health need and market opportunity for BioSensicsTeva Pharmaceuticalswho provided the financial support for our Phase I equivalent pilot workand the Huntington s Disease Society of America have expressed an interest in the proposed technology and are supportive of our effortssee Letters of Support