Feasibility of an Entirely Remote, Decentralized, Phase 3 Trial of a Light Therapy Device for Parkinson’s Disease
Sarrah Hussain1, Christi Alessi-Fox2, Melissa Kostrzebski2, Kathryn Murphy2, Michelle Porto2, Katrina Schmier2, Andrew McGarry3, Jamie Adams2, Pinky Agarwal4, Jason Aldred5, Kristin Andruska6, Alexander Baumgartner7, Jill Farmer8, Raja Mehanna9, Irene Richard2, Michael Soileau10, Matthew Swan11, Kara Wyant12, Kent Hendrix13, Suzanne Hendrix13, Dan Adams14, E. Ray Dorsey15
1School of Medicine, University of California, San Francisco, 2Center for Health + Technology, University of Rochester, 3Clintrex, 4Evergreen Health, 5Selkirk Neurology, 6CMDC, 7University of Colorado, 8Boro Neurology, 9University of Texas Health Science Center At Houston-McGovern Medical School, 10Texas Movement Disorder Specialists, PLLC, 11Mount Sinai Medical Center, 12University of Michigan, Neurology Dept, 13Pentara Corporation, 14Photopharmics, Inc., 15Atria Research and Global Health Institute
Objective:
To evaluate the feasibility of an entirely remote, decentralized phase 3 clinical trial of an investigative light therapy device for Parkinson’s disease.
Background:
Decentralized trials are increasingly common, but use in device studies remains limited.
Design/Methods:
This remote phase 3 trial, reviewed with the FDA, of a non-invasive light device aims to improve circadian function and quality of life in individuals with Parkinson’s disease. Participants were randomized to receive active or control light therapy for one hour every evening for six months. Devices were shipped directly to participants to use at home. All study activities occur remotely with coordinators located centrally and 16 investigators nationally. Participants communicate with coordinators and receive device use reminders through a smartphone application.
Results:
From February 2024 to October 2025, 5349 individuals submitted an online pre-screening form, 626 completed a screening visit, and 350 participants were enrolled from 17 states. Individuals who did not meet eligibility criteria or resided in states without licensed investigators were excluded based on a screening questionnaire. Subsequent screen failures were primarily due to low cognition (N=153) and investigator judgement (N=41).
Enrolled participants averaged 67.5 years old with 6.3 years disease duration. To date, participants have completed 80.5% of expected light therapy sessions. As of January 2026, 65 participants have withdrawn due to time commitment (N=17), adverse events (N=14), and life changes (N=7).
Conclusions:
Interest in this decentralized phase 3 clinical trial of a promising therapy was robust, and adherence to the study intervention has been high. Retention has been lower than a previous, traditional, site-based clinical trial perhaps due to limited pre-existing relationship with the study team, early operational challenges, and time demands. Decentralized trials hold promise for increasing access to clinical trials and may be especially well suited for geographically dispersed populations with limited mobility.
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