Status:
RECRUITING
Real-Time Levodopa Level Monitoring in Parkinson Disease
Lead Sponsor:
University of California, San Diego
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
This project aims to develop a minimally invasive sensor device to monitor levodopa levels in real time. We will test the accuracy, tolerability, and safety of this device in people with Parkinson dis...
Detailed Description
People with Parkinson disease (PD) lack the chemical dopamine, which is important for movement. Levodopa replaces dopamine and restores normal motor function in PD. Early in the disease stages, people...
Eligibility Criteria
Inclusion
- Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
- Able to provide signed informed consent (in English or Spanish)
- Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
- Taking instant release oral carbidopa/levodopa therapy
- Either not taking, or on stable doses of any of the following antiparkinsonian medications: dopamine agonists, monoamine oxidase B (MAO-B) inhibitors or catecholamine O-methyl transferase (COMT) inhibitors
Exclusion
- Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury
- Co-existent major psychiatric disease
- Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)
- Status post deep brain stimulation (DBS) device placement
- Any other condition, that in the opinion of the investigators, would place the participant at risk.
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04735627
Start Date
December 7 2021
End Date
February 1 2028
Last Update
February 11 2025
Active Locations (1)
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1
University of California San DIego
San Diego, California, United States, 92093