BOSTON- Parkinson’s disease researchers at Massachusetts General Hospital (MGH) have launched an observational substudy designed to test the feasibility and accuracy of using patient-owned smartphones to measure symptoms of Parkinson’s disease. These efforts are part of a larger NIH-funded clinical trial, called a “Study of Urate Elevation in Parkinson’s Disease, Phase 3 (SURE-PD3),” which examines whether an oral medication called inosine can slow progression of Parkinson’s disease.
As part of the smartphone substudy—which enrolled its first patient this week—participants will download and use a customized version of the iOS-based mPower application called ‘Smart4SURE.’ This application contains surveys that parallel those administered during clinic visits as well as structured activity tests that utilize the sensors in the phone to assess performance in movement tasks that are impacted by Parkinson’s disease – including walking, standing, tapping on the phone, and ‘saying ah.’
“Our hope is that we can use the power and ubiquity of smartphones to gather high-quality data from participants in our study,” says Michael Schwarzschild, MD, PhD, of the MGH Department of Neurology and the study’s lead investigator. “It can be challenging for some of our patients to come to the office for these assessments, so this technology has the potential to make study participation not only easier but more fruitful.”
Individuals will perform self-assessments on their phone at their regular study visits, which are spaced months apart, and at home on a weekly basis. The results of those assessments will be compared to those obtained in the clinic to determine whether they correlate and whether the data from the smartphone application provides additional insights not captured by traditional outcomes.
“Mobile technologies have been transformative to clinical research practice. This is a facile mechanism to expand study participation by enrolling a large distributed and diverse set of individuals,” says Lara Mangravite, PhD, president of Sage Bionetworks, which led the development and analysis of mPower and the Smart4SURE application. “It also provides the opportunity to monitor health and disease in a more frequent manner than is possible with in-clinic evaluations. We are enthusiastic that these approaches can also transform clinical trials.”
“Smartphones and other sensors provide a novel means to gather large volumes of objective data that have the potential to accelerate drug development for Parkinson’s disease and other neurodegenerative conditions,” says Ray Dorsey, MD, a professor of Neurology at the University of Rochester Medical Center and an adviser on the development of mPower and Smart4SURE. “This substudy in a phase 3 clinical trial in Parkinson’s disease is an important step in that effort.”
The SURE-PD3 clinical trial is funded by the National Institute of Neurological Disorders and Stroke in conjunction with the Michael J. Fox Foundation for Parkinson’s Research, and is being conducted at 60 sites of the Parkinson Study Group across the US. The Smart4SURE substudy is supported by the Burroughs Wellcome Fund and the National Institute of Neurological Disorders and Stroke.
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $800 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2016 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America’s Best Hospitals.
# # #