Pre-Screening Consent

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LIGHT-PD Pre-Screening Form

We are working on an exciting clinical trial conducted by Dr. Ray Dorsey from the University of Rochester's Center for Health and Technology (CHeT).

You may want to take part in this trial if you have a diagnosis of Parkinson's disease (PD) by a neurology specialist, are currently on a stable dose of medication to treat your PD, and have been medication to treat your PD for at least the past 1 year. The purpose of this trial is to evaluate a low intensity light-based device called the Celeste® phototherapy device that may be effective in treating the symptoms of Parkinson's disease.

If you are eligible to take part in this trial, you will be asked to use the device at home for 1 hour each day, for 6 months. You do not need to stare into the device- only have the light bathe your face while you are doing other things. We realize this is a big commitment! There are many things you can do while using the device, like having dinner, reading a book, doing puzzles, watching your favorite show, calling friends and family, and playing games or reading email on your tablet or phone. As long as you are sitting in front of the device with your eyes open, you can do whatever helps you pass the time most comfortably. If you have concerns about the commitment to using the device, or need take short breaks from using the device during the trial, you can talk with a member of the trial team about your concerns. Short-term adjustments may be made with the agreement of the trial team.

You will NOT be eligible to participate in the trial if you:

currently receive Deep Brain Stimulation (DBS) therapy, or are planning to receive DBS therapy before completing the 6-month trial
have an eye condition (such as severe cataracts or macular degeneration) that your doctor says needs surgery, or if you plan to have vision surgery while you are participating in the 6-month trial
are unable to reduce your dose of melatonin to no more than 5 mg per night while you are participating in the trial
take the supplement mucuna pruriens

There will be 4 scheduled visits over a 6-month period where you will complete assessments with a CHeT staff member to evaluate your general health, mood, behavior, every day functioning, daytime sleepiness, and fatigue. These assessments will be conducted using a private video (such as Zoom) tele-conference program while you are in your home.

Approximately 300 subjects will take part in this trial. Your participation will last about 6 months.

You may experience side-effects from using the phototherapy device such as headache, eye strain, feeling jittery or "wired", lightheadedness or nausea. These side-effects are typically short-term. There may be no direct benefit to you from participating in this trial. Your PD related symptoms may improve, worsen, or stay the same.

The University of Rochester is receiving payment from PhotoPharmics, Inc., the manufacturer of the Celeste Specialized Phototherapy device, for conducting this research trial.

You will receive $100 after each of the three treatment follow-up visits (Baseline, 13 weeks, and 26 weeks). You will also receive $200 when you return the light therapy device at the end of your participation. In total, you will be paid $500 for completing participation in this trial.

Before you agree to participate, there are some additional things you should know about the trial.

The University of Rochester will make every effort to keep the information collected from you private. In order to do so, we will store the information that you provide in a secure database and restrict access to only members on the LIGHT-PD trial team. Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the trial sponsor. If this happens, we will take precautions to protect the information you have provided. Results of the research may be presented at meetings or in publications, but your name will not be used.

If you agree to complete the information in the following questionnaire, please answer the questions yourself with minimal support from your caregiver. To be eligible for participation in the trial, an assessment that requires you to draw shapes and remember some words spoken to you by a member of the trial team must be completed by you, without caregiver support.

Would you like a member of the trial team to contact you if you appear eligible to participate?

Would you like a member of the study team to contact you if you appear eligible to participate?

Yes

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Optional Registration in the Neurology Study Interest Registry

The Neurology Study Interest Registry, also called Project:brain, is an established database of individuals interested in participating in neurology research studies and educational opportunities or other non-research programs, events and initiatives. The registry collects your contact information (i.e. name, email, phone number, address), demographic information (i.e., gender, date of birth, race, ethnicity), information about any neurological diagnoses (i.e., year of diagnosis, any medication taken), and any other relevant clinical items. If a research study, or other opportunity, arises that you consented to be notified about, and are eligible for, you will be informed via email and may choose to participate. Participants may request, either in person, via phone, or via email, to be withdrawn from the registry at any time.

If you would like to join the registry please click on the link below to sign up:

https://www.projectbrain.org/

Your participation in this study is completely voluntary. You are able to decline participation or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled.

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