HNF’s Wearable Tech Study Delivers Strong Results for CMT Clinical Trials

HNF’s Wearable Tech Study Delivers Strong Results for CMT Clinical Trials

The Hereditary Neuropathy Foundation (HNF) is breaking new ground in Charcot-Marie-Tooth (CMT) research with a pioneering study that uses wearable technology to monitor function in CMT patients. 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.

Addressing Challenges in CMT Clinical Trials 

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 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.

The Wearable Tech Pilot Study 

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.

Strong Results with Clinical Validation 

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.

A New Era for CMT Clinical Trials 

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.

HNF’s Role: 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.

For researchers, clinicians, and industry interested in participating in future studies, please reach out to Allison Moore at [email protected]