Wearable biosensors in movement disorders
- 1. Wearable Biosensor in Movement Disorders Trials Emily Kunka
- 2. Soft, flexible, conforming biosensor ● Vital signs ● Activity level/actigraphy ● Posture classification ● Electromyography (EMG) ● Muscle activation ● Sleep metrics Multiple sensors can be worn simultaneously to provide a synchronized stream of data points to contextualize natural behavior. MC 10’s BioStamp https://www.mc10inc.com/
- 3. ● QUALITY/COMPLIANCE - FDA 510K cleared, medical grade, clinical quality ● VALIDATED - Robust clinical trials, publications, usability testing, case studies ● CONFIGURABLE - Ability to manipulate sampling type and rate ● WELL- DESIGNED - Simple/straightforward, intuitive interface and application ● USER EXPERIENCE - Comfortable, unobtrusive, and discreet to wear/adhere ● DATA ACQUISITION - Ideally passive data collection (i.e. bluetooth) ● COMPATIBILITY - API to integrate with third party systems or other devices ● DATA INTEGRITY/SECURITY - Data is transmitted and stored securely in the cloud ● ACCESSIBLE ANALYTICS - Dashboard for remote monitoring and reporting Best-Fit Selection Criteria
- 4. Value-Added Real World Data Evidence-based repeated measures represent a more accurate picture of the subject’s functional abilities, disease status, and response to therapy. Inter-rater variability and bias are reduced, ensuring measure reliability and objectivity. Data is collected in real-time and may uncover novel endpoints. Time and Cost Savings Burden Reduction ● Patients spend less time performing assessments, affecting enrollment and retention. ● Simplified workflows for study teams (less data entry, reduced capacity for transcription error, single unit replacing disparate systems or devices). ● Potential for fewer visits. ● Can reduce or replace requirements for copious outcome assessments. ● Eliminate need to identify, qualify, and utilize additional facilities (i.e. nerve conduction or sleep lab) ● Device is small, reusable, easy to ship and make available at scale.
- 5. Time Savings Cost Savings Comments Assessment ● Assessment will still occur at Baseline and EOT ● Occurrence removed at visits 3, 5, and 9 3 hours per pt $150 1 Timed 25 Foot Walk Test *Estimated at 1 hour with set-up and instruction ● Assessment was at visits 3, 5, and 7 ● Assessment removed completely from schedule of assessments 1.5 hours per pt $75 2 Barnes Akathisia Rating Scale (BARS) *Estimated at 0.5 hour ● Only occurring in person at a lab at Screening and Baseline visits ● All other assessments taken via the sensor at visits 2, 4, 6, 8 and 10 5 hours per pt (investigator time) $1,000 3 Electromyography Study Application Phase IIb study; N = 50 participants; 10 visits per participant Total 9.5 hours per pt $1,225 per pt $61,250 for 50 participants *Estimated to take 1 hour in a lab