Direct-to-participant study to reach 150 people living with ALS, with 2 participants already enrolled.
NEW YORK, Sept. 26, 2024 /PRNewswire/ — In a first-of-a-kind collaboration, Target ALS, a foundation breaking down barriers to amyotrophic lateral sclerosis (ALS) research to find effective treatments, and Modality.AI, whose platform measures what patients say and do in conversation with the virtual guide Tina, in-clinic and remotely, are conducting a study to evaluate the potential of this unique audiovisual platform to detect even the smallest changes in disease symptoms over time in ALS patients. A subset of 5 international sites, part of the Target ALS Global Natural History Study, is now recruiting 150 ALS and 50 healthy control participants and will deploy Modality.AI’s innovative digital health platform, including at locations in Spanish-speaking countries, over the next 3 years.
Participants will engage in twice-monthly Modality sessions over a period of 16-18 months, utilizing the platform’s self-directed assessment accessible on personal devices. Tina, a virtual guide, provides consistent engagement while capturing speech and facial biomarkers.
Results from this pioneering study will be made available to the research community on the Target ALS Data Engine.
Study Details
Participants will be consented in the clinic and then asked to complete twice-monthly Modality sessions at home. Sessions include a reading passage, spontaneous speech, activities of daily living such as brushing their hair and washing their face, and various cognitive tasks such as word recall and sequential movements. Modality works through a web browser, so no app installation or account creation is required.
Modality’s Platform Offers Unique Advantages
The assessment is self-directed and takes place on a participant’s own device (computer, tablet, or phone), making it accessible in the convenience of their home. For trial sponsors, this minimizes the need for in-clinic assessment and the time and cost of shipping devices.The introduction of Tina, a virtual guide, encourages engagement through a welcoming interface for capturing the patient’s speech and facial biomarkers in a comfortable setting in just a few minutes. Tina provides consistent guidance, eliminating variance between clinicians, a confounding variable in studies.Modality’s cloud-based platform utilizes AI and multimodal signal processing to extract speech and facial measures from participants’ video in real time for immediate verification and analysis.The Patient Report of Problems™ (PROP™) allows trial participants to describe specific problems and symptoms in their own words. This study marks the first use of the PROP in a multilingual multicenter ALS Study.
Improving Study Participation, Retention, and Participant Diversity
Advances in digital health technologies (DHTs) allow patients to participate in clinical research studies in the privacy and comfort of their own homes, rather than traveling to an investigator’s site.
Most DHT-based studies rely on continuous monitoring of patients or require patients to record activities in an electronic diary regularly. Modality’s approach is a brief speech and movement assessment led by a virtual guide, assuring privacy for participants and those around them. Target ALS and Modality adhere to recognized privacy standards with data being used for research purposes only.
A well-known trial challenge is that access to trial sites is a significant burden for many. Giving patients the option to participate from home increases the likelihood of joining a study, reduces drop-out rates, and increases adherence to the study protocol. By reaching a wider range of patients, underrepresented groups are more readily included, which helps ensure that treatments can be effective over the widest possible population.
“We are delighted to participate in what is the first clinical study of Modality’s self-directed remote monitoring of speech and motor function with Target ALS,” said Modality.AI CEO, David Suendermann-Oeft. “Speech, language, video, and other multimodal analysis technologies may revolutionize remote neurological assessments. We look forward to this collaboration and our work together leading to more efficient clinical trials and, in turn, faster and more efficient drug discovery.”
“Modality.AI’s technology is at the forefront of digital health technologies being evaluated for the utility of predicting and tracking disease progression in ALS patients,” said Amy Easton, Senior Director of Scientific Programs at Target ALS. “These technologies are being developed to allow clinicians, patients, and caregivers to measure disease symptoms in a more sensitive and reliable manner than standard clinical assessments, and in the future, may even replace clinical outcome assessments used to evaluate novel treatments for ALS.”
To learn more about participating in this study click here.
About Target ALS
Founded in 2013, Target ALS is a 501(c)(3) medical research foundation breaking down barriers to Amyotrophic Lateral Sclerosis (ALS) research to find effective treatments. The organization has revolutionized ALS research through their landmark Innovation Ecosystem model, fostering unprecedented collaborations between academia and the pharma and biotech industry, providing no-strings-attached access to critical research tools, and acting as a hub of communication and networking for the worldwide scientific community. Driven by impatient optimism, deliberate disruption, and radical collaboration, Target ALS aims to transform ALS into a manageable disease, realizing a world where Everyone Lives. For more information, visit www.targetals.org
About Modality.AI
Modality.AI has developed the first conversational AI platform to accurately and objectively measure, analyze and track participant data through facial, speech, and movement patterns. The Modality platform utilizes a virtual guide, Tina, to remotely administer clinical trial assessments. The company is led by a team of world-class scientists, clinicians, technologists, and serial entrepreneurs. Modality’s platform has shown validation through numerous peer-reviewed publications (https://modality.ai/publications), and is being used by leading research institutions, biotech firms, and top-10 pharmaceutical companies in observational studies and clinical trials. For additional information, please visit modality.ai
Contact
Stephanie Ishoo
stephanie.ishoo@targetals.org
David Fox
david.fox@modality.ai
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SOURCE Target ALS
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