Summary
The transformative power of technology is never more evident than in stories that change people’s lives. One such story begins with Celestra Health, a Canadian health technology company that developed a digital biomarker for Multiple Sklerosis (MS). The company uses sensor insoles to improve the lives of people with MS by developing a real-life MS disease monitoring solution.
Why MS disease monitoring matters
MS is an inflammatory disease of the central nervous system that affects approximately 2.8 million people worldwide. (1)
Changes in gait pattern play a crucial role in this (2,3) and are also a suitable starting point for targeted monitoring of the disease.
In people with MS gait disorders occur in many cases. This is because the central nervous system, which consists of the brain and spinal cord, gets affected. The spinal cord and the cerebellum are particularly impacted.
The spinal cord is important for transmitting signals between the brain and the body. It helps control and adjust these signals. The cerebellum is responsible for coordinating various movements and plays a major role in balance. It acts as a central hub between different parts of the brain and the spinal cord. (4)
Both are particularly vulnerable to damage in people with MS. Inflammation and damage to the myelin sheath, which protects nerve fibers in a healthy state, frequently occur in these areas. In 92 percent of people with MS, inflammatory lesions are found in the spinal cord, leading to damage in these regions. (5-7) This results in motor deficits such as weakness and spasticity in the lower extremities, as well as sensory deficits and gait instability that characterize gait disturbances. For example, there may be weakness and stiffness in the legs, and the leg muscles may feel weak or constantly tense. The senses can also be affected, such as balance perception, which can cause individuals to walk unsteadily and uncoordinated.
So one of the major challenges in treating MS is to detect and analyze changes in patients’ gait as it provides valuable information about the disease progression.
During a relapse, difficulties can worsen, but they can be now for the first time directly addressed in daily life through gait analysis, such as the system offered by Celesta Health. It can also be explored whether medication intended to have a positive effect on gait shows the desired results.
The journey of Celestra Health, a Canadian healthcare company, began out of the need of a digital biomarker to visualize the progress of MS in real life in order to make informed treatment decisions.
Challenging sensor based gait monitoring
With MS, there is no predictable course of the disease. Deteriorations often occur suddenly and in relapses.
However, visits to the doctor to check the course of the disease usually take place only once or twice a year.
How can be ensured that there is no deterioration during this period that would permanently affect the state of health? How can be monitored whether the prescribed medication is fulfilling its purpose and if the patient is responding well to it? More frequent visits to the doctor are not a viable solution, either from an economic or a medical point of view.
It was therefore necessary to find a solution that would allow gait analyses to be performed under normal living conditions, providing laboratory-quality insights into the daily lives of those with the disease.
An early warning system for disease progression between controls was needed. By recording individual gait patterns several times a week, it would be possible for the first time to accurately measure the effect of pharmacological and personalized rehabilitation treatments. The Celestra Health solution needed to be able to detect and identify MS-specific gait patterns and measure the effects of disease-typical fatigue on gait patterns to register even minor changes in gait.
Celestra AI + Moticon Sensors & Integrations = Solution
The idea for an AI-powered, wearable, digital biomarker was born. The medical and technical knowledge to develop a corresponding app was available. What was missing was the right sensor insole.
To perform medically valid gait analysis, a sensor insole was needed that could reliably provide accurate data and offer the ability to link proprietary software to the sensor insole’s software.
“After evaluating multiple smart insoles vendors from around the world, we selected Moticon as our preferred partner due to their product maturity, their best-in-class technical support and their innovative features such as auto-calibration. It is very important for us to work with a partner whose product has been clinically validated in over 90 scientific publications and who has well-known customers such as Regeneron, Nike, Adidas and Novartis.” comments Bruce Ford, CEO of Celestra Health.”
Achievements leading to phase-I clinical trial
“We had a great idea and Moticon was the solution to our problems in creating our product. Moticon sensor insoles incorporate pressure sensors and an inertial measurement unit (IMU) to measure movement in space. In addition to the hardware, one of the things we were really impressed with, was the quality of their software and the ease we were able to integrate it into our smartphone app. Without the Moticon Software there would be no way for us to control the smart insoles. Within six weeks we had a working prototype. Within ten weeks the combined software was production ready. This is a remarkable achievement by any measure. The technical support we received from Moticon towards the integration phase was excellent. The more we learned about the Moticon ReGo product, the more impressed we were. The simple calibration was only a small part of it. Moticon is a company that clearly pays attention to detail to ensure that the overall user experience is star.”
Feedback from the recently completed Phase I study at the University of Ottawa has been extremely positive. Celestra Health’s technology offers an unobtrusive way to continuously monitor the condition of MS patients and develop personalised treatments with the goal of improving their quality of life.
Wrap Up
Starting in June 2023, Celestra Health will be starting a multi-site Phase II trial, in conjunction with the Brigham and Women’s Hospital (Boston, US), Barts Health (London, UK) and the Ottawa Hospital (Ottawa, Canada), leading to commercial availability in 2024.
The precise data that can be collected through the sensor insoles helps ensure the overall quality and effectiveness of Celestra Health’s wearable solution.
The collaboration of Celestra Health with Moticon represents a significant step forward towards an integrated, real-life MS disease monitoring solution, ultimately benefiting MS patients worldwide.
Sources
(1) https://www.atlasofms.org/map/global/epidemiology/number-of-people-with-ms
(2) Coca-Tapia, M., Cuesta-Gómez, A., Molina-Rueda, F., & Carratalá-Tejada, M. (2021). Gait Pattern in People with Multiple Sclerosis: A Systematic Review. Diagnostics (Basel), 11(4), 584. https://www.mdpi.com/2075-4418/11/4/584
(3) Heesen C, Böhm J, Reich C, Kasper J, Goebel M, Gold SMM. Patient perception of bodily functions in multiple sclerosis: Gait and visual function are the most valuable. Mult Scler. 2008;14(7):988–91.
(4) Nógrádi, A. & Vrbová, G. Anatomy and Physiology of the Spinal Cord. In: Madame Curie Bioscience Database [Internet]. 2000. Accessible at: https://www.ncbi.nlm.nih.gov/books/NBK6229/
(5) Eden D et al.: Spatial distribution of multiple sclerosis lesions in the cervical spinal cord. Brain. 2019;142(3):633-646. Doi: https://doi.org/10.1093/brain/awy352
(6) Weier K et al. Biplanar MRI for the assessment of the spinal cord in multiple sclerosis. https://doi.org/10.1177/1352458512442754
(7) Hua, L. H., Donlon, S. L., Sobhanian, M. J., Portner, S. M., & Okuda, D. T. (2015). Thoracic spinal cord lesions are influenced by the degree of cervical spine involvement in multiple sclerosis. Spinal Cord, 53(5), 520-525. Published: 13 January 2015. https://www.nature.com/articles/sc2014238
