Wearable Tech Study Delivers Strong Results for CMT Clinical Trials

Hereditary Neuropathy Foundation aims to de-risk CMT clinical trials and improve outcomes by incorporating FDA-registered wearable devices for remote monitoring

NEW YORK, NY, UNITED STATES, October 15, 2024 /EINPresswire.com/ -- Charcot-Marie-Tooth (CMT), a hereditary motor and sensory neuropathy, leads to progressive weakness and sensory loss in the arms and legs, causing difficulties in balance, frequent falls, and impaired hand function. Despite advancements in research, CMT clinical trials continue to face significant hurdles, including the logistical burdens of travel, cost, and difficulties in accurately measuring disease progression in real-life settings. Participant retention is also a common challenge. HNF has compiled a team that aims to close these gaps and derisk upcoming clinical trials for CMT with emerging wearable technologies.

HNF is breaking new ground in CMT research with a pioneering study that uses wearable technology to monitor function in CMT patients. HNF has been at the forefront of CMT advocacy and research for over a decade, using its Global Registry for Inherited Neuropathies (GRIN) patient registry and lessons learned from past clinical trials to drive improvements. With this new wearable technology initiative, HNF aims to remove many of the barriers that have historically hindered CMT clinical trial success. In partnership with BioSensics™, this pilot study was introduced at the CMT Clinical Trial Readiness Summit in June, 2024. HNF aims to overcome key challenges in CMT clinical trials and improve outcomes by incorporating FDA-registered wearable devices for remote monitoring.

At the summit, HNF and BioSensics launched the “Wearable-Based Remote Monitoring Upper and Lower Limb Function in CMT Pilot Study.” The study utilizes BioSensics' wearable device, PAMSys™ which is lightweight and non-invasive, similar to a pendant. These devices were provided to participants attending the summit, along with on-site training, to ensure ease of use. The wearable devices continuously monitored participants’ daily activity levels while they went about their lives at home, offering real-world data on how CMT affects day-to-day function.

The study, led by HNF Fellowship recipient Dr. Kayla Cornett, proved to be a significant step forward in remote data collection for CMT trials. Participants found the devices easy to use, non-invasive, and appreciated the long battery life, leading to high compliance throughout the study. The continuous data captured by the wearable devices provided detailed insights into the amount of daily activity patients were engaging in. This kind of information is invaluable for understanding the real-world impact of CMT and how future therapeutics can improve patients' lives. Importantly, the data collected from the wearable sensors correlated well with established clinical outcome measures of disease severity in CMT patients, providing strong preliminary validation for this technology.

HNF’s leadership in this study has the potential to revolutionize the way CMT clinical trials are conducted. By using wearable technology to monitor patients in their home environments, trials can become more accessible and effective, removing barriers like travel and time commitments and providing more accurate, real-life data for researchers.

“Understanding the impact of CMT in patients’ daily lives is crucial so that future therapeutics can benefit individuals in their home environment,” said Dr. Cornett. This study marks an important step forward in HNF’s mission to drive advancements in digital health technologies for CMT. With the initial success and validation of wearable devices, HNF is paving the way for more inclusive, accessible, and impactful clinical trials that will bring new treatments to the CMT community.

As the driving force behind this groundbreaking initiative, HNF continues to lead the way in advancing research and improving the lives of individuals with CMT. By leveraging new technologies and collaborative partnerships, HNF is opening doors to better, more effective clinical trials, ensuring that future treatments succeed for the CMT community.

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For researchers, clinicians, and industry interested in participating in future studies, please reach out to Allison Moore at allison@hnf-cure.org.

About Hereditary Neuropathy Foundation:
HNF’s mission is to increase awareness and accurate diagnosis of Charcot-Marie-Tooth (CMT) and related inherited neuropathies, support people living with CMT and their families with critical information to improve quality of life, and fund research that will lead to treatments and cures. HNF’s Therapeutic Research in Accelerated Discovery (TRIAD) is a collaborative effort with academia, government, and industry to develop treatments for CMT. As part of TRIAD’s research consortium, the Global Registry for Inherited Neuropathies (GRIN) was established as a patient registry to collect and analyze patient-reported data and clinical scales, including the ONLS, CMT-FOM, CMTPedS, and CMTInfS and the collection and curation of genetic reports. The data has been instrumental in identifying the burden, diagnostic journey, and prevalence of CMT. In 2022, HNF launched the CMT Genie, a patient-initiated genetic testing program to support genetic diagnosis by offering patients virtual genetic counseling with an option to obtain a prescription to seek a genetic diagnosis.

About BioSensics™:
BioSensics™ is the leader in developing wearable sensors and digital health technologies for clinical trials and research, remote patient monitoring, and health assessments. Founded in 2007 by three scientists from Harvard, BioSensics™ has created new paradigms in using wearable sensors in healthcare and revolutionized the medical alert industry by creating technologies that are now used by thousands of older adults. BioSensics™ is the only company that offers comprehensive end-to-end solutions and services for the acquisition of digital measures and biomarkers in clinical trials and research. BioSensics™ designs and validates all elements of their solutions, including wearable sensors, software, and algorithms. Our experienced research team extends complete scientific and technical consultation services, such as study design and protocol development, in addition to statistical analysis. Furthermore, the BioSensics™ clinical operations team provides comprehensive operational and logistics support for clinical trial projects. BioSensics™ has received over $50M in research and development program support from the U.S. National Institute of Health (NIH). In 2022, BioSensics™ was chosen by NIH to create remote measurement technologies for use in clinical trials involving people with rare diseases.

Allison Moore
Hereditary Neuropathy Foundation
+1 917-648-6971
email us here
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