This blog series shares what’s happening day-to-day in our Innovation Lab long before we share the results in publications or at conferences. The VeraSci Innovation Lab was created to pair scientific knowledge with cutting-edge technology to improve the tools and measurements available for use in clinical trials.
Wearables represent a unique opportunity to capture clinical data in ways that haven’t been possible previously. The underlying goal of incorporating wearables is to reduce burden by collecting more measurements with less effort. After an extensive review of the current wearable/sensor landscape, VeraSci selected a wrist worn wearable, the Empatica E2, and the Moticon Science Pro+ wireless shoe insoles to investigate in the Innovation Lab. While many consumer devices are less expensive than the devices selected, they have some significant shortcomings that led us to select research grade devices for our use.
Repurposing consumer wearables, like Fitbits, for clinical research has been attempted by others in many indications; however, they have significant drawbacks compared to research grade devices. Consumer wearables are updated frequently and support for legacy consumer wearables is limited. We wanted devices that could be used by the research community to follow patients over long periods of time. Selection of devices that could not support protocols of long durations would severely limit the types of studies VeraSci and others could conduct and the usefulness of our findings. Consumer wearable data portals also require personal information for registration which has led to privacy concerns. Consumer device companies have not taken steps to ensure that this information is protected in accordance with HIPAA regulations. Additionally, the quality and reliability of the data generated by consumer grade devices isn’t sufficient for research purposes.
We examined the features of research grade devices including, size, weight, durability and patient placement. The devices we ultimately selected were designed to increase subject compliance and use to ensure ease of data collection. The most important component used in the selection process were the data quality metrics of these devices. The accuracy, reliability, sensitivity and potential for clinical relevance of the endpoints collected. Higher reliability results in the need for less patients and lower errors means that improvements from an intervention or deterioration from a disease can be more accurately attributed. Features that also played a large part in the selection process were wireless connectivity, battery life, onboard memory, and secure cloud-based repository for captured data.
We evaluated numerous sensors currently available that would support our indications of interest and scored them under a variety of criteria. We selected the Empatica E2 and Moticon Science Pro+ because they excel in factors such as patient usability, data frequency, data quality, and fit for purpose for the population being studied initially.
The Empatica E2 is a wrist worn device with a variety of sophisticated sensors designed to gather data on a subject’s heart rate, motion activity, skin temperature and electrodermal properties. The device data can be streamed via Bluetooth to a smartphone in real time to examine data remotely. The secure E2 connect platform allows for secure viewing and CSV download of the raw data for analysis, and are also accessible in real-time via mobile APIs for iOS and Android. The E2 was one of very few devices able to measure electrodermal activity (also known as Galvanic Skin Response) in conjunction with activity with accurate timing.
Data collected on Empatica devices have appeared in numerous published papers on a variety of indications including dementia. Pharmaceutical Sponsors have used Empatica devices as endpoints in clinical trials. Additionally, the E2 has been cleared by FDA for use in the detection of seizures.
Moticon Science Pro+
We were interested in a wearable that could measure gait because of the potential for broad use with CNS disorders such as multiple sclerosis, neuromuscular disorders, and Alzheimer’s disease. The Moticon Science Pro+ insoles can collect passive data regarding a subject’s gait and movement. Force, pressure and balance between right and left are measured dynamically as well as the temporal and spatial parameters of motion quality and ground contact. The insoles are Medical Device certified (ISO 13485) and feature adjustable sampling rates, 13 pressure sensors, 3-axis accelerometer, low power antenna and onboard memory. These are housed in a form factor that is unobtrusive and comfortable, which fits within a subject normal routine, allowing for strong adherence. The devices can also be controlled wirelessly by either a smartphone or a PC/laptop.
The Moticon software also creates meaningful reports (in addition to the raw data) based on specified endpoints and time periods.
The Moticon Science Pro+ insoles can calibrate themselves against each other (right and left), while many other devices in this class require a difficult and often inaccurate calibration process to ensure data accuracy. The passive data mode that allows for 14 days of data recording without charging or uploads was also seen as a differentiator.
Another key feature is the open data API that permits the incorporation of Moticon data into VeraSci’s existing data management platform. Moticon’s commitment to data privacy and the creation of a HIPAA compliant cloud infrastructure was another factor we considered. The Moticon Science Pro+ is also being used by numerous esteemed academic institutions, a large pharmaceutical Sponsor, and the US Department of Defense.