Pre-Screening Consent

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LIGHT-PD Pre-Screening Consent Form

We are working on a study conducted by a study doctor from the University of Rochester's Center for Health and Technology (CHeT).

You may want to take part in this study if you have a diagnosis of Parkinson's disease (PD) by a neurology specialist, are on a stable dose of medication to treat your PD, and you have relatively good eye-sight. The purpose of this study is to evaluate a low intensity light-based device called the Celeste® phototherapy study device that may be effective in treating the symptoms of Parkinson's disease. The study device is considered "investigational," which means it has not been approved for use by the U.S. Food and Drug Administration (FDA).

If you are eligible to take part in this study, you will be asked to use the study device at home for 1 hour every day. You do not need to stare into the study device, you only have the light bathe your face while you are doing other things like having dinner or reading a book. There will be 4 instances 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 (feeling tired). These assessments will be conducted by telephone and/or using a private video (such as Zoom) tele-conference program while you are in your home.

We estimate that approximately 300 subjects will take part in this study. Your participation will last about 6 months.

You may experience side-effects from using the phototherapy study device such as:

Headache
Eye strain
Dry eyes
Teary eyes
Feeling jittery or "wired"
Lightheadedness
Nausea

These side-effects are typically short-term. There may be no direct benefit to you from participating in this study. 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 study device, for conducting this research study.

You will receive compensation for your participation in the study.

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

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 study team.

Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the study sponsor. If this happens, we will take precautions to protect the information you have provided. While every effort will be made to protect the confidentiality of your information, absolute confidentiality cannot be guaranteed.

Results of the research may be presented at meetings or in publications, but your name will not be used.

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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