Orikami Uses CTTI's Novel Endpoints Recommendations to Build and Validate a Digital Biomarker to Monitor Fatigue in Multiple Sclerosis Patients
Orikami BV Applies CTTI's Novel Endpoints Recommendations
2. Define the scope of assessment and determine if identification of fatigue as a biomarker will positively affect MS patients. For example, even if fatigue could be better tracked, would it improve the lives of patients? Since fatigue is highly correlated with MS disease progression, improved identification of this health aspect could trigger a meaningful change in treatment that may improve patient lives.
3. Find the appropriate and exact measurement for fatigue. Was eye movement and reaction time the right concept of interest to target? Orikami's research concluded that delayed visual response was in fact a significant indicator.
4. Find the right mobile technology. Should Orikami work with only one platform, or could they target a diverse range of devices? Is the front-end camera theoretically capable in terms of framerate, contrast sensitivity, and resolution?
5. Determine the standards for use. For example, at what, if any, point would dim lighting make detection of eye movement unreliable? How close to the eyes should patients hold their phone? Is the movement of holding the smartphone disturbing the signal? The Orikami team assessed many factors and created guidelines to ensure they developed the appropriate proof-of-concept tests in this phase.
6. After rigorously going through each of the previous steps, Orikami was ready to show validity in a clinical study. At the time of this writing, that study is ongoing. Orikami's strong protocol is testing a range of setups of stimuli on the screen to see how people with MS and healthy controls react to these. The study is exploring the sensitivity of change on published measures of fatigue, as well as correlations with disease activity, relapses, and progression.For a detailed look at Orikami's journey with CTTI's Novel Endpoints Recommendations, visit this blog authored by the development team.