Brain Dopamine Biomarker

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of South Florida

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

Qualifiers

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 design

Treatments tested in this trial

  • Levadopa/Carbidopa eyedrops
  • Sham
  • Levodopa/Carbidopa (Sinemet)

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of South Florida

Lead sponsor

Center for Neuromusculoskeletal Research

Collaborator