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

This trial accepts healthy volunteers

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 population

Adults ages 18 years and above. Adults will be either healthy controls or have confirmed diagnosis of Parkinson's disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Levadopa/Carbidopa eyedrops

    Drug

    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

    Other intervention

    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)

    Drug

    Parkinson's patients will self-administer their medication and measurements will be taken prior to and 15-30 minutes after self-administration.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Healthy controls2 interventions
Group B: Parkinsons1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 measurements separated by 1 hour

Secondary outcomes

1

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).

Time frame
2 measurements separated by 1 hour

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

Center for Neuromusculoskeletal Research

Collaborator

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