SBIR-STTR Award

The objective is to design and clinically assess ETAware, an adaptive, wearable system to monitor the impact of tremor on activities of daily living (ADL) for the evaluation and optimization of therapeutic interventions in patients with essential tremor (ET) as there is currently no technology that can assess the functional impact of tremor on ADL. ETAware will focus on ET, the most common movement disorder, affecting 10 million people in the US; however, commercially, the system will have applications for other conditions that hinder engagement in daily activities and affect quality of life. Currently, propranolol and primidone are the two main drugs used for treating essential tremor, while surgical interventions such as deep brain stimulation (DBS), and MRI-guided focused ultrasound (MgFUS) are warranted in medically refractory ET. Nevertheless, patients' responses to all forms of therapy can vary substantially, necessitating the sequential use of different drugs. To evaluate the effectiveness of interventions, it is critical to quantify both tremor severity and its impact on ADL in ET. Currently, to show clinical improvement, subjective questionnaires and rating scales are used. However, these questionnaires and rating scales are subject to clinical judgment and bias, only provide information at a discrete point in time, and cannot be utilized for daily continuous monitoring. ETAware will continuously monitor tremor severity AND the functional impact of tremor on ADL, which will help clinicians with therapy adjustments, help patients take control of their disease management, and improve research and clinical trials by providing an objective quality of life measure and minimizing the costs associated with clinic visits and the administration of questionnaires and rating scales. We have previously commercialized wearables and mobile apps that are currently used in drug clinical trials for monitoring upper limb tremor severity. However, the existing systems do not quantify lower limb tremor or give any information on the impact of tremor on ADL. The primary innovations of ETAware are 1) signal processing algorithms to analyze motion sensor data and provide continuous measurements of the functional impact of tremor on ADL, 2) a system for clinicians to optimize therapy, researchers to evaluate and develop new therapies, and patients to stay involved in their disease management. To demonstrate feasibility in Phase I, motion data will be collected from 20 patients with essential tremor while they are performing TETRAS-based tremor performance and ADL tasks as well additional functional tasks. Success criteria include 1) development and validation of signal processing algorithms that correlate (r = 0.76, root-mean-square error =0.5) kinematic data with clinician's TETRAS-based tremor performance and ADL scores, and 2) development and validation of machine learning models that accurately (sensitivity/ specificity/AUC > 0.8) identify physical activities such as walking, sitting, standing, getting out of a chair, going up and down stairs.Public Health Relevance StatementNarrative The objective is to design and clinically assess ETAware, an adaptive, wearable system to monitor the impact of tremor on activities of daily living (ADL) for the evaluation and optimization of therapeutic interventions in patients with essential tremor (ET) as there is currently no technology that can assess the functional impact of tremor on ADL. Successful commercialization of ETAware will improve patient quality of life by maximizing drug effectiveness, reducing the time and costs associated with clinic visits, and improving access to healthcare for geographically disparate populations.

Project Terms:
Activities of everyday life; daily living function; daily living functionality; functional ability; functional capacity; Activities of Daily Living; Affect; Algorithms; AD dementia; Alzheimer Type Dementia; Alzheimer disease dementia; Alzheimer sclerosis; Alzheimer syndrome; Alzheimer's; Alzheimers Dementia; Primary Senile Degenerative Dementia; primary degenerative dementia; senile dementia of the Alzheimer type; Alzheimer's Disease; Clinic Visits; Clinical Trials; Data Collection; Decision Making; Disease; Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Dystonia; Muscle Dystonia; Fingers; Patient Care; Patient Care Delivery; Orthostatic Hypotension; Postural Hypotension; Judgment; Lower Extremity; Lower Limb; Membrum inferius; Living Wills; living will; Magnetic Resonance Imaging; MR Imaging; MR Tomography; MRI; MRIs; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; NMR Imaging; NMR Tomography; Nuclear Magnetic Resonance Imaging; Zeugmatography; Motion; Movement Disorders; Dyskinesia Syndromes; Movement Disorder Syndromes; Persons; Parkinson Disease; Paralysis Agitans; Parkinson; Primary Parkinsonism; Patients; Primidone; Desoxyphenobarbital; Misodine; Propranolol; Propanolol; Quality of life; QOL; Questionnaires; Research; Research Personnel; Investigators; Researchers; Rest; Rural Population; Rural group; Rural people; rural individual; Sensitivity and Specificity; Stroke; Apoplexy; Brain Vascular Accident; Cerebral Stroke; Cerebrovascular Apoplexy; Cerebrovascular Stroke; brain attack; cerebral vascular accident; cerebrovascular accident; stroked; strokes; Technology; Time; Tremor; Work; Measures; Walking; measurable outcome; outcome measurement; Outcome Measure; Caring; Titrations; Drug Approval Processes; sensor; improved; Clinical; Refractory; Phase; Medical; Evaluation; Physical activity; Visual; Limb Tremors; Individual; Measurement; drug use; Drug usage; Device Approval Process; Device Approval; Benign Essential Tremor; Essential Tremor; Disease Management; Disorder Management; Deep Brain Stimulation; Severities; System; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Performance; success; kinematics; kinematic model; Participant; Therapeutic Intervention; intervention therapy; Membrum superius; Upper Limb; Upper Extremity; Effectiveness; Symptoms; Data; Effectiveness of Interventions; Improve Access; Monitoring Clinical Trials; Observational Study; Observation research; Observation study; Observational research; Validation; validations; Monitor; Process; Development; developmental; Output; cost; under served group; under served individual; under served people; under served population; underserved group; underserved individual; underserved people; Underserved Population; designing; design; Clinical assessments; Outcome; innovate; innovative; innovation; new drug treatments; new drugs; new pharmacological therapeutic; new therapeutics; new therapy; next generation therapeutics; novel drug treatments; novel drugs; novel pharmaco-therapeutic; novel pharmacological therapeutic; novel therapy; novel therapeutics; commercialization; evidence base; improve symptom; symptom improvement; symptomatic improvement; clinical decision-making; mobile app; mobile device application; mobile application; signal processing; Focused Ultrasound; access to health care; access to healthcare; accessibility of health care; accessibility to health care; accessibility to healthcare; health care access; health care service access; health care service availability; healthcare access; healthcare accessibility; healthcare availability; healthcare service access; healthcare service availability; health care availability; wearable electronics; wearable system; wearable technology; wearable tool; wearables; wearable device; patient specific response; responsive patient; patient response; therapy optimization; treatment optimization; motion sensor; assess effectiveness; determine effectiveness; effectiveness assessment; evaluate effectiveness; examine effectiveness; effectiveness evaluation; geographic disparity; geographic disadvantage; geographic inequality; geographic inequity; geographic location disparity; machine learning model; machine learning based model; Disparity population; disadvantaged group; disadvantaged individual; disadvantaged people; disadvantaged population; disadvantaged subgroup; disparities across groups; disparity across subgroups; disparity among groups; disparity among subgroups; disparity between groups; disparity between subgroups; group disparity; group inequality; group inequity; inequalities among populations; inequalities between populations; inequalities in populations; inequality across populations; inequality among groups; inequality between groups; inequality in groups; inequities among populations; inequities between populations; inequities in populations; inequity across groups; inequity across populations; inequity between groups; inequity in groups; population inequality; population inequity; subgroup disparity; unequal group; unequal population