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Brain Dopamine Biomarker
Sponsor: University of South Florida
Summary
This study is being conducted at the Morsani College of Medicine to determine whether signals recorded from the eyes and brain can be used as a noninvasive way to monitor dopamine function. Approximately 50 adults (25 with Parkinson's disease and 25 without Parkinson's disease) will participate. Participants will undergo electroretinography (ERG) and electroencephalography (EEG), which are FDA-approved, noninvasive devices that measure electrical activity from the retina and brain using sensors placed on the skin around the eyes and scalp. Participants with Parkinson's disease will be tested before and after taking their prescribed Parkinson's medication (e.g., Sinemet® \[carbidopa/levodopa\]). Participants without Parkinson's disease will receive a single dose of compounded levodopa/carbidopa eye drops (an FDA-approved drug used in an unapproved ophthalmic formulation) in one eye and a placebo eye drop in the other eye. The placebo consists of the same vehicle solution without levodopa/carbidopa and contains 0.1% ascorbic acid, 0.001% benzalkonium chloride, and phosphate-buffered saline. Randomization will be used to determine which eye receives the levodopa/carbidopa eye drop and which eye receives the placebo. Researchers will compare measurements obtained before and after treatment to evaluate whether blue-light visual responses are associated with dopamine activity.
Official title: Blue Color Processing in the Eye as a Biomarker of Brain Dopamine
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-10-01
Completion Date
2027-09-30
Last Updated
2026-08-12
Healthy Volunteers
Yes
Interventions
Levadopa/Carbidopa eyedrops
Topical levodopa/carbidopa eyedrops (1.4/0.34 microM) in a base of 0.1% w/v ascorbic acid and 0.001% w/v benzalkonium chloride dissolved in 1× phosphate-buffered saline.
Sham
The vehicle (control) solution will consist of 0.1% w/v ascorbic acid and 0.001% w/v benzalkonium chloride dissolved in 1× phosphate-buffered saline.
Levodopa/Carbidopa (Sinemet)
Parkinson's patients will self-administer their medication and measurements will be taken prior to and 15-30 minutes after self-administration.