ALS patients can now apply to participate in citizen-led multi-modal digital biomarkers study for prognosis and diagnosis of ALS with a goal towards use in drug trials for neurological diseases
SAN FRANCISCO, Sept. 19, 2022 /PRNewswire-PRWeb/ -- EverythingALS, a patient-focused non-profit that brings together people living with ALS, caregivers, physicians, researchers, and pharmaceutical companies to collaborate on an open innovation platform using cutting-edge technologies and data science to improve progression measurements for neurological disease like Amyotrophic Lateral Sclerosis (ALS), has initiated a new study, The Radcliff Study, with partners in the quest to find a diagnosis, treatment, and cure for ALS. EverythingALS is teaming up with Aural Analytics, a leader in clinical-grade speech analytics, FeetMe, a medical device company that produces smart and connected insoles for improved running, walking and gait analysis, ZEPHYRx, a leading provider of end-to-end remote respiratory monitoring solutions, and a major pharmaceutical company. The Radcliff Study is a novel research-as-a-feasibility study to inform the likelihood of success for a pre-competitive collaboration focused on developing an end-to-end digital alternative for the ALSFRS-R that supports clinically meaningful outcomes tailored for use in ALS. There is not one test or procedure to establish the diagnosis of ALS and there is also no known cure or treatment options available.
The Radcliff Study is a multidisciplinary study focused on gait analysis, pulmonary function testing, and speech analytics to make strides towards a digital biomarker. The study uses AI, remote patient monitoring technologies, and algorithms to determine possibly clinically meaningful characteristics for persons living with ALS.
The research study requires participants to partake in a series of tasks that help track and monitor changes in speech, walking and breathing. Unlike traditional medical tests that need to be done in a medical office, all Radcliff Study components can be completed at home.
"EverythingALS is excited to work with Aural Analytics, FeetMe and ZEPHYRx on this unique study," said Indu Navar, Founder of the Peter Cohen Foundation and CEO of EverythingALS. "This is the first time that companies are working in conjunction to capture quantifiable data that could change how ALS and other neurodegenerative diseases like ALS, Alzheimer's and Parkinson's are treated and diagnosed."
The Radcliff study is named after Tom Radcliff, an ALS patient who fought to find a cure for ALS before passing away from the disease. "It's an honor to know Tom's legacy is continuing on through the study," said Erin Radcliff, Tom's wife. "He fought tooth and nail to help find a cure for ALS before he passed and more importantly, he cared about other ALS patients, having been through the treacherous diagnosis phase himself and then living with the disease for a year before he passed. The Radcliff Study honors his legacy by putting the focus on patients and allowing them to be heard. It's amazing what strength in numbers can accomplish, especially in the ALS community."
Aural Analytics will be providing tech that can analyze participant's speech patterns. "We are looking forward to the impact of the Radcliff Study through the partnership with EverythingALS and the participating organizations," said Judy Smythe, Chief Executive Officer of Aural Analytics. "Speech is a leading objective data stream that is highly sensitive to subtle motor changes in the speech of ALS participants. We are highly optimistic about the powerful combination of speech, gait, and pulmonary function."
Participants of the Radcliff Study will be wearing FeetMe smart insoles for gait analysis. "We want to support this research effort to build new and innovative disease specific markers and potentially help to detect earlier signs of ALS with non-invasive digital technology disease evolution. It will be powerful to see the combination of multiple high quality data sources in this multimodal study to improve disease knowledge," said Alexis Mathieu, Founder and Senior Advisor of FeetMe. "Motor impairment is a common feature across neurodegenerative disorders, and we are expecting to see subtle changes thanks to real world data collection."
The ZEPHYRx solution will collect pulmonary function test data from participants and share that data with the study team in real-time through a cloud-based platform. "Having the ability to perform a pulmonary function test at any moment and from the comfort of home is fundamental for study participants with neuro-muscular diseases like ALS," said Mike DiCesare, President of ZEPHYRx. "We're thrilled to be a part of this research study as spirometry is an important indicator of ALS disease progression."
Some of the inclusion criteria are:
· Are 18 or older
· Can provide informed consent
· Fully able to communicate
· Able to read and write intelligibly in English
· Own a smartphone and able to download and consent to App usage without assistance
· Independently ambulate without gait assistive devices
· Able to ascent and descend stairs independently safely
· Have been diagnoses with ALS by a neuromuscular specialist or people who have ALS as a consideration for a cause of their symptoms
Recruitment will open shortly, and anyone interested in participating can get more information and apply at: http://everythingals.org/research.
About EverythingALS
EverythingALS is a patient-focused non-profit, part of Peter Cohen Foundation, a 501(3)c organization, bringing technological innovations and data science to support efforts -- from care to cure -- for people with ALS, by offering an open-data platform for direct engagement with patients, caregivers, researchers, and drug companies. For more information, please visit: http://www.EverythingALS.org
About Aural Analytics
Aural Analytics is the industry's leading speech neuroscience company harnessing the clinical utility of the world's speech across the age range and around the world. Their suite of applications and embeddable SDKs and APIs are available in 25 languages across Android, iOS, and the web are easy to use, secure, and provide robust, clinically relevant, interpretable, and validated metrics reflecting the neurological and respiratory health of its users. For more information, please visit:
http://www.auralanalytics.com/
About FeetMe
FeetMe is a certified medical device company developing smart medical wearables to improve mobility based on connected insoles. The innovative technology from FeetMe allows gait and posture analysis in real-time and real-life conditions. The technology combines pressure sensors, motion sensors and learning algorithms to analyze patients' functional capacity, as well as empower rehabilitation among sufferers of gait disorders. FeetMe proposes the world's first and most advanced technology platform for real-world disease diagnostics, monitoring and rehabilitation based on movement data. For more information, please visit:
http://www.feetmehealth.com/
About ZEPHYRx
ZEPHYRx is a leading provider of end-to-end remote respiratory monitoring solutions. Our solutions combine a cloud-based provider dashboard with real-time video coaching, patient mobile app, and MIR's FDA-cleared spirometer. Our mission is to empower patients to actively manage and improve their own respiratory health through leading-edge technology and gamification. For more information, please visit: http://www.zephyrx.com/
Media Contact
Cassandra Weller, EverythingALS, 1 610-297-1047, [email protected]
SOURCE EverythingALS
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