The ALS Never Surrender Foundation, a volunteer-based, non-profit organizations on a mission to cure Motor Neuron Disease and Amyotrophic Lateral Sclerosis (ALS) announced a $300,00 grant from the ALS Association to bring its ALS iNVOLVE/eNGAGE app to MND/ALS patient progression research trials across the U.S.. The precision point mobile technology app allows patients to remotely track over 80 metrics of range of motion, muscle control, dexterity, breathing, speech and other key vitals on a universal platform, creating an exponentially richer patient progression database to study.
ALS is often referred to as Lou Gehrig’s disease. It is a progressive neurodegenerative disease that slowly robs the body of its ability to walk, speak, swallow and breath. Living with an ALS diagnosis means coping with symptoms that change, yet most ALS patients only see their clinical support team once every three months, which means changes are only tracked four times a year. With the average survival rate of an ALS patient being two to five years from diagnosis, that means there are only between 8 and 20 points in time logged using these traditional methods.
Progression surveys in clinical trials are often subjective, and at times patients fail to accurately report the changes with their mobility—often because they seek to establish a positive tone and outlook or conversely, to protect family members from their pain and suffering with disease advancement.
The Clinical Trials
The clinical trials will commence in November, 2019 with 50 patients of all ages, genders and geographies across five ALS medical research sites including Harvard/Massachusetts General Hospital, Duke University, Barrow Neurological Institute, University of California, San Diego and the University of Colorado, Denver.
Built on the Claris FileMaker Workplace Innovation Platform, (Apple subsidiary) the developers will partner with experts from Google AI, IBM Watson and Apple for physical measurement data analysis and Aural Analytics for speech and breathing analysis. This app will support patient self-monitoring in addition to the support of clinical teams in their effort to proactively collaborate and support patients’ requests and needs as symptoms morph and change. This app will help investigators accumulate important data supporting analysis of trends associated with new MND/ALS therapy impact.
With this app researchers can now gather 116,000 data points per patient from diagnosis till death as opposed to other technologies which gather just 240 points of data per patient for same term. Ultimately the app should help investigators accumulate more progression data and hence contribute to superior worldwide approaches to study ALS progression research trends. It also supports the overall research efforts to find ALS treatments.
Of note the ALS involve/eNGAGE app is also supported by Aural Analytics speech analytics platform which tracks vocal biomarkers (components of speech) to measure, subtle, but clinically relevant speech changes in patients by tapping directly into various nervous system functions.
FDA Submission for Approval
The ALS Never Surrender Foundation aims to submit for U.S. Food & Drug Administrative Approval for the ALS iNVOLVE/eNGAGE app to be used as a medical device and make it accessible to the 35,000 ALS patients in the U.S. and the 250,000+ ALS patients worldwide.
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