Raising the Bar in CNS Endpoint Measurement
In 1968, Dick Fosbury changed our expectations of Olympic high-jumping. By going over the bar backward, he changed the sport forever and literally set the bar higher for achieving world records.
A number of factors led to this accomplishment for Fosbury. Most importantly, the introduction of the landing mat, which enabled athletes to explore new options for getting over the bar, now that they weren’t required to land on their feet (figure 1).
What if right now, we had access to new tools – like the landing mat –- that could allow us to raise the bar in how we develop CNS disorder treatments? Could we create the clinical equivalent of the Fosbury Flop and change what we expect of CNS treatments to really make a difference in the lives of patients with Parkinson’s disease, Epilepsy, and other movement disorders?
Limits of Traditional CNS Endpoint Measurement Tools
Traditional methods of assessing movement disorders, such as clinical rating scales, are subjective and prone to human bias. And, while consumer-grade activity monitors like Fitbits and the Apple Watch provide objective data, their primary focus is to track activity, not how well the activity was performed or which findings correlate to clinical outcomes.
Unfortunately, in clinical development, activity tracking data often isn’t robust enough to accurately characterize the differences between affected patients and normative controls. These devices don’t provide any insight into how the disease affects a patient’s overall functional mobility (the full spectrum of issues related to gait, balance, ability to turn, ease of rising and sitting, etc.) or measure specific data that indicates disease progression or therapy response.
High Precision Wearable Sensors – the ‘Landing Mat’ that can Change CNS Endpoint Measurement
Just as the landing mat reinvented how athletes approached high jumping, the right wearables platform could be the game-changer that reinvents clinical endpoint measurement to enable the development of more effective movement disorder treatments.
ERT’s Opals® Wearables Sensors & Mobility Lab® platform technology is the leading wearables platform for precision motion analytics and digital biomarkers. Born out of a decade of studies conducted by the world’s top scholars and clinical researchers in movement science and disorders, the proven platform is validated to provide high fidelity data and consistent performance across multiple settings, providing insight into functional mobility in both prompted clinic assessments and real-world activities of daily living (see figure 2).
How High Precision Wearables and Digital Biomarkers Work
ERT’s approach is to focus not simply on activity monitoring or step counting but to focus objectively on how people move and how those digital biomarkers correlate to indication-specific clinical measures of disease progression or treatment response.
Differing from activity trackers, multiple sensors can be deployed in different configurations, so that when worn on different areas of the body they can simultaneously measure specific aspects of functional mobility. For instance, a single Opal sensor worn on foot or lower back can measure walking speed, stride length, foot strike angle and adding sensors to other areas of the body such as torso, head or arms can discern things such as body sway angle, speed of turning and steps within a turn or even measure the angle of joint movement during activities- providing more insight into how multiple aspects of mobility impacts patients’ lives. They can even identify predictors of safety such as fall risk. So, in the same platform, you can capture efficacy and safety measures that complement PRO and clinical evaluations to inform QOL measurements.
Unlike high jumping, where usually the recommendation is ‘don’t try this at home,’ the Opal Sensor technology is meant to be used anywhere. This type of precise movement measurement was previously only achievable through optical motion capture in very complex lab settings, but now the wearable Opal Sensors can enable high precision movement analysis during the course of the patients’ activities of daily living. Think of it as measurement at the point of experience . So now, instead of a few single point in time assessments , you can measure in the clinic, at home, and even leverage continuous monitoring to generate real-world data on true functional mobility.
The Records Speak for Themselves
And just like in the Olympic games, what’s in the record book counts, so we are racking up our results.
The value of the Opal Sensor has been documented in over 500 scientific publications, validating our technology and outcome measures as functional endpoints and biomarkers. In fact, our expertise is so deep that our scientific teams’ work has been cited more than 45,000 times in the literature. Our expert clinical and regulatory team works closely with you to help you leap ahead by leveraging our 150+ validated functional endpoints to create the winning solution for your trial.
By using ERT’s high precision wearables and digital biomarkers to reinvent endpoint measurement, clinical trial sponsors can raise the bar in developing more effective treatments for movement disorders. With Opal Sensors, patients receive meaningful insights into disease diagnosis and progression and sponsors achieve more predictable, cost-effective, and efficient clinical trials.
It’s time for a Fosbury Flop in CNS endpoint measurement. Contact us today to speak with one of our experts who can coach you on how incorporating a proven wearables and digital biomarkers clinical trials solution can raise the bar in building the body of evidence on the safety and efficacy of your movement disorder treatment.
Jim Mahon is the Vice President and Chief Strategy and Marketing Officer at ERT