Wearable Inertial Sensor Technology Produces Endpoints with Good Reliability in Healthy Volunteers and Can Detect Changes in Parkinson Disease Patients with Levodopa (P6.086)

Objective: To evaluate the performance of wearable inertial sensor technology in quantifying Parkinson Disease (PD) signs Background: Objective monitoring of Parkinson Disease (PD) signs is important to adequately assess response to treatments. Currently, PD treatments are adjudicated based on expert clinical rating scales and patient diaries, which are often insensitive, episodic and subjective with inherent rater bias. Wearable inertial sensor technology, such as the Mobility Lab system (www.apdm.com) can quantify gait metrics, and have been studied to monitor PD signs. Design/Methods: We compared endpoints of the Mobility Lab 2-minute walk test in 41 healthy volunteers (HV) and in 25 PD patients. HV have two test sessions at least 1 hour apart. Each PD patient also performed the task twice: one in ON state (~1 hour after scheduled levodopa dose) and again in OFF state (immediately prior to next scheduled levodopa dose). PD patients were randomized with half performing ON state evaluations first, and vice versa. Each subject walked 10 meters back and forth for two minutes while wearing sensors at each limb, sternum and lumbar regions. Results: We found the highest reliability of the following endpoints in HV: cadence (Pearson’s r =0.9860), stride length ( r =0.963), and arm range of motion ( r =0.962). In PD patients, Mobility Lab endpoints including turn duration ( p= 0.003), gait speed ( p = 0.009), stride length ( p = 0.006) and arm range of motion ( p = 0.02) significantly differed before and after levodopa intake, and correlated with the Unified Parkinson Disease Rating Scale Motor Score (e.g. turn duration r = 0.4). Conclusions: The Mobility Lab System 2-minute walk test generated endpoints with good reliability and detected changes in PD patients before and after levodopa. Wearable inertial sensor technology has potential to enhance our ability to detect signals of effectiveness in therapeutics development. Study Supported by: Pfizer, Inc. and IBM Disclosure: Dr. Ramos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. Dr. Naylor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. Dr. Demanuele has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. & Biogen, Inc. Dr. Zhang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer Inc. Dr. Amato has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. Dr. Hameed has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. Dr. Wacnik has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, inc. Dr. Kangaroo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, inc. Dr. Anand has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with IBM. Dr. Bilal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with IBM. Dr. Ho has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. Dr. Bergethon has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer and Biogen. Dr. Erb has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer, Inc. Dr. Karlin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Pfizer Inc.