About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parkinson's subjects will have received physician verified diagnosis of the disease and be on a dopaminergic medication for at least 3 months
Disqualifiers
Any movement, strength, or balance assessments that may pose a potential risk for injury
Individuals with a history of photosensitive epilepsy or seizure activity triggered by visual stimuli
Current use of antipsychotics, stimulants, or other medications known to affect central dopaminergic transmission
Pregnancy
Trial population
Adults ages 18 years and above. Adults will be either healthy controls or have confirmed diagnosis of Parkinson's disease.
Trial design
Cohort
Prospective
Treatments tested in this trial
Levadopa/Carbidopa eyedrops
DrugTopical 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
Other interventionThe 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)
DrugParkinson's patients will self-administer their medication and measurements will be taken prior to and 15-30 minutes after self-administration.
Treatment groups
Trial outcomes
Primary outcomes
Electroretinography
Electroretinography (ERG) is used to diagnose and evaluate the conditions of the retina and optic nerve, including photoreceptors and ganglion cells, by measuring the electrical activity generated by retinal cells in response to light stimulus. The ERG will be performed using the FDA-approved RETeval® device. Specific variables of interest include ERG latency, amplitude, and coherence.
Secondary outcomes
Electroencephalography
EEG is a non-invasive method to monitor brain activity. By collecting EEG data, we will identify patterns and markers in the brain associated with dopamine signaling and observe how and if they change with the interventions. We will utilize the ANT Neuro wireless headsets that supply 64-channels of data from locations of the international 10-10 system. Specific variables of interest include event-related potential latency, amplitude, and band power (absolute, relative, ratios).
Locations
Sponsors and contacts
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University of South Florida
Lead sponsor
Center for Neuromusculoskeletal Research
Collaborator
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