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Vigor and the LDR in Parkinson Disease

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ClinicalTrials.gov Identifier: NCT04821830
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Roger L. Albin, University of Michigan

Brief Summary:
Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for PD is the drug levo-dopa, which partially replaces brain dopamine. Despite decades of successful use, how levo-dopa improves speed of movement in PD is not understood. This observational study recruits participants who have been prescribed levo-dopa by their treating physicians. Before their first dose, immediately after their first dose and later, when their dose has been stabilized, they will engage with the research team to participate in a few simple experiments to measure speed, grip strength, tremor, and stability (on and off of treatment). The purpose of these experiments is to understand how levo-dopa treatment in Parkinson disease enhances movement speed. An important but not understood component of levo-dopa action, the Long Duration Response (LDR), lasts for days to weeks. A basic function of dopamine signaling in the brain is modulation of motivation - the coupling between effort and action values. These experiments will determine if the LDR is associated with relative normalization of motivation function in the brain. The motivation behavior of recently diagnosed PD participants will be examined before and after treatment with levo-dopa to determine if the magnitude of the LDR is correlated with improvements in motivation behavior.

Condition or disease Intervention/treatment
Parkinson Disease Drug: carbidopa/levodopa, as prescribed by treating physician

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vigor and the LDR in Parkinson Disease
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 12, 2022
Estimated Study Completion Date : February 12, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's disease patients who take levo-dopa as standard of care
Participants will undergo evaluation of the relationship between the LDR and movement vigor. All participants will undergo standard evaluation with standard clinical rating scales and three outcome measures: Tapping Speed Task - Measurement of Bradykinesia; Grip Strength Task - Measurement of Incentive-Outcome Coupling - Movement Vigor; Joystick Movement Task - Measurement of Incentive-Outcome Coupling - Movement Vigor. Some participants may opt in to an additional training and evaluation: Value Driven Attentional Oculomotor Capture.
Drug: carbidopa/levodopa, as prescribed by treating physician

There will be 4 measurement states:

at baseline prior to chronic treatment initiation (OFF-No LDR); at baseline after a standard, acute oral dose (25/250 carbidopa/L-dopa), referenced in the protocol, but prescribed and provided by their prescribing physician as standard of care initial dosage (ON-No LDR); 2 months after initiation of chronic, stable L-dopa treatment (amounts and sequences as prescribed by treating physicians) but with no L-dopa for 10-12 hours prior to evaluation (Practical OFF- LDR); and after resuming subjects' usual physician-prescribed L-dopa dose (ON-LDR).

Other Name: Parcopa, Sinemet




Primary Outcome Measures :
  1. Tapping Speed Task [ Time Frame: 15 Minutes ]
    Measurement of Bradykinesia

  2. Grip Force Task [ Time Frame: 20 Minutes ]
    Measurement of Incentive-Outcome Coupling - Movement Vigor

  3. Joystick Movement Task [ Time Frame: 20 Minutes ]
    Measurement of Incentive-Outcome Coupling - Movement Vigor

  4. Value Driven Attentional Oculomotor Capture Task [ Time Frame: 1 Hours ]
    Measurement of Value Signal Stability



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is newly diagnosed Parkinson disease in the early stages of PD (Hoehn & Yahr Stages I & II).
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson Disease
  • Previously Untreated or treated for <4 weeks
  • Mild to Moderate Parkinson disease (Hoehn & Yahr Stages I-II)
  • About to start treatment with a L-Dopa preparation (Sinemet)

Exclusion Criteria:

  • The presence of other neurologic disease or findings on examination
  • Depression: Geriatric Depression Scale score >11
  • Use of dopamine agonists or stimulants
  • Evidence of a stroke or mass lesion on prior structural brain imaging (MRI or CT)
  • Evidence of any confounding medical or psychiatric problem that would preclude task participation.
  • Participants with cognitive impairment that might impair their capacity to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821830


Contacts
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Contact: Kacee Pavelka 734-763-2211 kapavelk@med.umich.edu
Contact: Roger L Albin, MD 734-764-1347

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kacee Pavelka, BS    734-763-2211    kapavelk@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Roger Albin University of Michigan
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Responsible Party: Roger L. Albin, Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT04821830    
Other Study ID Numbers: HUM00166765
R21NS114749 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Roger L. Albin, University of Michigan:
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists