Effort integrates digital mobility data for Parkinson’s research

Wearable EmbracePlus device now able to collect Mobilise-D's DMOs

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by Mary Chapman |

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Remote health monitoring company Empatica is partnering with the consortium Mobilise-D to advance the use of digital endpoints in clinical care and research across disorders that include Parkinson’s disease.

The collaboration will integrate Mobilise-D’s validated digital mobility outcomes (DMOs) with Empatica’s Health Monitoring Platform. With this, all such DMOs can be measured with Empatica’s flagship medical wearable EmbracePlus and accessed through the platform, consolidating advanced mobility analytics. The wrist-worn device contains sensors that enable it to collect study-specific data to better assess patients’ mobility, potentially aiding treatment development, clinical practice, and precision medicine.

“We are proud to be the first non-consortium member to implement the Mobilise-D consortium’s groundbreaking development and validation work, ” Simone Tognetti, Empatica’s chief technology officer and co-founder, said in a press release. “This means our platform can now provide 25 new, validated outcomes for chronic obstructive pulmonary disease (COPD), Parkinson’s disease, multiple sclerosis (MS), and proximal femoral fracture. The demand for high-quality, purpose-specific measures is immense and Empatica is ready to support the dissemination of the consortium’s innovative work within the industry.”

Boston-based Empatica is a pioneer in digital biomarker development and artificial intelligence-driven patient monitoring. Its FDA-approved platform is said to be used by thousands of institutional partners for studies on stress, sleep, migraine, epilepsy, depression, addiction, and other conditions. The EmbracePlus device was developed with partners that include the U.S. Department of Health and Human Services, the U.S. Army Medical Research and Development Command, and the NASA-funded Translational Research Institute for Space Health.

Mobilise-D is funded by the European Union’s Innovative Medicines Initiative along with the European Federation of Pharmaceutical Industries and Associations partners, and coordinated by Newcastle University in the U.K. It’s made up of academic experts, pharmaceutical, technology, and clinical research organizations, and patients with varied health conditions and mobility impairments.

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Incorporating mobility data in care, research

The consortium’s chief goal was to develop an innovative way to evaluate changes in patients’ mobility in real-world environments using digital technologies, including a body-worn device. The focus was on conditions that affect mobility, such as Parkinson’s, COPD, MS, congestive heart failure, and hip fracture recovery. Mobility and balance are commonly affected in Parkinson’s, which results in rigidity, tremor, and slowed movement, among other symptoms.

Mobilise-D is said to be the first public program to generate reliable evidence for digital measures through systematically combining device considerations, clinical and analytical validation, and patient and regulatory engagement.

“A major barrier to the implementation of digital outcomes in clinical trials is the availability of systems that can deliver accurate and reliable data in a timely and seamless manner,” said Lynn Rochester, a professor at Newcastle University and Mobilise-D co-lead. “We are delighted that Empatica have chosen to integrate the Mobilise-D advanced mobility analytics, addressing this barrier and moving digital outcome assessment closer to a sustainable solution that drives much needed innovation and harmonization in clinical trials.”

The combination of Mobilise-D’s algorithms and Empatica’s service and technology makes inclusion in pharmaceutical studies easier, mitigating patient and site burden, according to Empatica. “The critical support from key pharmaceutical companies in the pipeline development leading to the dissemination of these endpoints highlights the collaborative effort required to drive innovation in the industry,” the press release states. “Utilizing the algorithms in interventional clinical trial settings is a key step toward the regulatory approval of digital endpoints in clinical drug development.”