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Social Decision Making in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pramipexole

Placebo

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Impulsive behavior, Social decision making, Moral decision making, dopamine agonists

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 45-80
Ability to give informed consent
Idiopathic Parkinson's disease
Currently taking dopamine agonist therapy
Mild symptom severity (Hoehn & Yahr ≤ 3)
Disease duration of <12 years
Demonstrated positive response to dopamine therapy

Exclusion Criteria:

Medications classes that influence GABA concentrations: benzodiazepines, cholinesterase inhibitors, antipsychotics, opioids, and MAO inhibitors
History of substance abuse or use of any psychostimulants (other than caffeine) in the last 6 months or more than 4 times in lifetime
Current tobacco (or nicotine use) or alcohol intake greater than 8 ounces of whiskey or equivalent per week
Comorbid neurological disorders (e.g., stroke, peripheral neuropathy, seizure disorder) or history of head trauma (other than a single concussion)
Unstable medical condition, [e.g., diabetes or pulmonary disease, significant medical condition, including high blood pressure (systolic B.P. > 135, Diastolic B.P. > 85), or any hepatic, renal, cardiovascular, hematological, endocrine or ophthalmological condition]
History of major psychiatric illness (including any affective disorder, substance use disorder, psychotic disorder, or eating disorder)
Dementia
Deep brain stimulation
Contraindications to 3 Tesla MRI, e.g., extreme obesity, claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body
Dyskinesia or tremor that would cause severe motion artifact during MRI scan
Clear indication of secondary gain

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Impulsive group, placebo then pramipexole

Impulsive group, pramipexole then placebo

Non-impulsive group, placebo then pramipexole

Non-impulsive, pramipexole then placebo

Arm Description

half of the impulsive group will first get the placebo on the first day and pramipexole on the second day

half of the impulsive group will first get the pramipexole on the first day and the placebo on the second day

half of the non-impulsive group will first get the placebo on the first day and the pramipexole on the second day

half of the non-impulsive group will first get the pramipexole on the first day and the placebo on the second day

Outcomes

Primary Outcome Measures

The change in a harm aversion cognitive moral decision-making task

change in harm aversion from off drug visit to on drug visit

change in blood flow in the ventral striatum per ASL images

change in CBF from off drug visit to on drug visit

Secondary Outcome Measures

Full Information

NCT ID

NCT04249544

First Posted

January 28, 2020

Last Updated

October 16, 2023

Sponsor

Vanderbilt University Medical Center

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04249544

Brief Title

Social Decision Making in Parkinson's Disease

Official Title

Cognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine Agonists

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

December 3, 2019 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinsons Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Pramipexole. For the off-DAA visit, participants will receive a placebo. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.

Detailed Description

Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications to reduce circulating drugs and residual drug effects. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinson's Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Carbidopa-Levodopa 1 hour before the scan and will take 1mg of Pramipexole 1 hour before the scan. For the off-DAA visit, participants will take Carbidopa-Levodopa 1 hour before the scan and will take a placebo 1 hour before the scan. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Impulsive behavior, Social decision making, Moral decision making, dopamine agonists

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Impulsive group, placebo then pramipexole

Arm Type

Experimental

Arm Description

half of the impulsive group will first get the placebo on the first day and pramipexole on the second day

Arm Title

Impulsive group, pramipexole then placebo

Arm Type

Experimental

Arm Description

half of the impulsive group will first get the pramipexole on the first day and the placebo on the second day

Arm Title

Non-impulsive group, placebo then pramipexole

Arm Type

Experimental

Arm Description

half of the non-impulsive group will first get the placebo on the first day and the pramipexole on the second day

Arm Title

Non-impulsive, pramipexole then placebo

Arm Type

Experimental

Arm Description

half of the non-impulsive group will first get the pramipexole on the first day and the placebo on the second day

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Intervention Description

1mg of pramipexole

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1mg equivalent of placebo

Primary Outcome Measure Information:

Title

The change in a harm aversion cognitive moral decision-making task

Description

change in harm aversion from off drug visit to on drug visit

Time Frame

two weeks

Title

change in blood flow in the ventral striatum per ASL images

Description

change in CBF from off drug visit to on drug visit

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 45-80 Ability to give informed consent Idiopathic Parkinson's disease Currently taking dopamine agonist therapy Mild symptom severity (Hoehn & Yahr ≤ 3) Disease duration of <12 years Demonstrated positive response to dopamine therapy Exclusion Criteria: Medications classes that influence GABA concentrations: benzodiazepines, cholinesterase inhibitors, antipsychotics, opioids, and MAO inhibitors History of substance abuse or use of any psychostimulants (other than caffeine) in the last 6 months or more than 4 times in lifetime Current tobacco (or nicotine use) or alcohol intake greater than 8 ounces of whiskey or equivalent per week Comorbid neurological disorders (e.g., stroke, peripheral neuropathy, seizure disorder) or history of head trauma (other than a single concussion) Unstable medical condition, [e.g., diabetes or pulmonary disease, significant medical condition, including high blood pressure (systolic B.P. > 135, Diastolic B.P. > 85), or any hepatic, renal, cardiovascular, hematological, endocrine or ophthalmological condition] History of major psychiatric illness (including any affective disorder, substance use disorder, psychotic disorder, or eating disorder) Dementia Deep brain stimulation Contraindications to 3 Tesla MRI, e.g., extreme obesity, claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body Dyskinesia or tremor that would cause severe motion artifact during MRI scan Clear indication of secondary gain

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard R Darby, M.D.

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

12. IPD Sharing Statement

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Social Decision Making in Parkinson's Disease

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