Real-Time Levodopa Level Monitoring in Parkinson Disease
Real-Time Levodopa Level Monitoring in Parkinson Disease
This project aims to develop a minimally invasive microneedle sensor to monitor levodopa
 levels in real time. We will test the accuracy, tolerability, and safety of this device in
 people with Parkinson disease.
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 with PD benefit significantly from levodopa. However, as PD
 progresses, the brain loses more dopamine-producing cells, which causes motor complications
 and unpredictable responses to levodopa. To maintain control of symptoms over time, levodopa
 doses must be increased and given at increasingly shorter intervals. The optimal levodopa
 regimen is different for each person and may vary from day-to-day, depending on a variety of
 internal and external factors including meal consumption, activity level, and other lifestyle
 variances. Currently, clinicians assess levodopa's benefit by the patient's testimony and by
 clinical exam. However, these methods may not adequately represent the severity or range of
 complications experienced by the PD patient. Thus, it can be difficult to determine the
 optimal levodopa treatment regimen, which can cause suboptimal disease management and side
 effects.

 This project aims to develop a continuous, minimally invasive microneedle device placed on
 the skin (the "Levodopameter") designed to continuously measure levodopa levels in real time,
 with the future goals of identifying an individualized treatment regimen for people with PD
 to improve disease management. We will compare levodopa levels measured by the Levodopameter
 to the impractical and expensive "gold standard" high-performance liquid chromatography
 (HPLC) analysis of plasma levodopa levels. We will first test the device after administering
 oral carbidopa/levodopa in 10 participants with PD. After that portion of the study is
 completed and safety confirmed, we will test the device in 10 participants with PD after
 administering carbidopa and intravenous levodopa. We will also evaluate the device's safety
 and tolerability.

 The long-term goal of this device is to allow PD patients to take proactive measures to
 assess and maintain an optimal, personalized levodopa regimen, similar to diabetes care in
 which diabetic patients periodically self-monitor their glucose and adjust their insulin
 regimen accordingly.
Inclusion Criteria:

 1. Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for
 clinically established Parkinson disease.

 2. Able to provide signed informed consent (in English or Spanish)

 3. Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages
 I-IV)

 4. Taking instant release oral carbidopa/levodopa therapy

 5. 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 Criteria:

 1. Other neurological conditions including but not limited to stroke, dementia (including
 Parkinson disease dementia), or traumatic brain injury

 2. Co-existent major psychiatric disease

 3. Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure,
 diabetes, etc.)

 4. Status post deep brain stimulation (DBS) device placement

 5. Any other condition, that in the opinion of the investigators, would place the
 participant at risk.