- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558766
Motor Cortex Reward Signaling in Parkinson Disease
Background:
The brain releases signals to mark rewards for certain behavior. Some medications for Parkinson disease (PD) can cause some patients to engage in compulsive behavior, possibly because the medications affect this reward system.
By using transcranial magnetic stimulation (TMS), researchers can study brain activity when an individual receives a reward.
Objectives:
To learn how the brains of people with PD behave when rewarded.
To learn whether two common Parkinson medications (levodopa and pramipexole) change this behavior.
To compare reward signals in the brains of healthy volunteers with reward signals in the brains of people with PD.
Eligibility:
Women between 50 and 80 years of age and men between 45 and 80 years of age.
Participants will be divided into healthy volunteers and volunteers who have mild to moderate PD.
Design:
Prescreening will consist of a neurological examination and a series of questions about gambling habits and drug and alcohol use.
Participation in a TMS study involving a computer game simulation of a slot machine:
- Before the simulation, participants will receive TMS to establish a baseline response rate.
- During the simulation, participants will play a game in which they will receive real money.
TMS will be administered to each patient under three different conditions:
- TMS administered when patients have not taken any Parkinson medication.
- TMS administered after patients have taken levodopa.
- TMS administered after patients have taken pramipexole....
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
HEALTHY SUBJECTS:
-Age 45-70 years
PATIENTS:
- Mild-moderate disease (Hoehn and Yahr stage 1-2).
- Age 45-70 yrs
EXCLUSION CRITERIA:
- Pre-menopausal status in women: Preliminary data in healthy, cycling women suggests that the variation in paired-pulse inhibition caused by the menstrual cycle may obscure the change in the response induced by the behavioral task.
- Significant neurological or psychiatric history other than PD
- Exposure to DA agonists within a month of study
- History of habitual gambling, defined as either visiting casinos more than once per month or playing cards for money more than once per week or gambling over the internet more than once per month
- Habitual consumption of more than two drinks a day, marijuana more than once a week or any other illicit drug use within the last three months
- Significant abnormality on neurological examination other than PD related signs
- Metal in the cranial cavity or eye, pacemaker, implanted pumps or stimulators
- Use of non-PD related medications affecting the DA system, such as phenothiazine antihistamines (promethazine), antiemetics or decongestants in the last month
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- Avanzi M, Uber E, Bonfa F. Pathological gambling in two patients on dopamine replacement therapy for Parkinson's disease. Neurol Sci. 2004 Jun;25(2):98-101. doi: 10.1007/s10072-004-0238-z.
- Cohen MX, Young J, Baek JM, Kessler C, Ranganath C. Individual differences in extraversion and dopamine genetics predict neural reward responses. Brain Res Cogn Brain Res. 2005 Dec;25(3):851-61. doi: 10.1016/j.cogbrainres.2005.09.018. Epub 2005 Nov 11.
- Strobel A, Spinath FM, Angleitner A, Riemann R, Lesch KP. Lack of association between polymorphisms of the dopamine D4 receptor gene and personality. Neuropsychobiology. 2003;47(1):52-6. doi: 10.1159/000068876.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080023
- 08-N-0023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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