Parkinson DiseaseNCT00558766
Motor Cortex Reward Signaling in Parkinson Disease
An observational study of Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2007to 13 Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HEALTHY SUBJECTS:
- -Age 45-70 years
- PATIENTS:
- Mild-moderate disease (Hoehn and Yahr stage 1-2).
- Age 45-70 yrs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the detailed description
The role of mesencephalic dopamine neurons in reward processing has been established in primates using electrophysiological techniques and in humans using functional neuroimaging. Their role is thought to be dual: i) they show sustained activity with the expectation of a future reward and ii) a phasic response after reward. Animal data indicate that these neurons, located in the midbrain areas A8-10, behave as a single functional unit when activated. They have rich projections to both the prefrontal and motor cortices where they synapse on interneurons and cortical pyramidal cells, producing primarily inhibition. Though their function is not fully understood, these projections clearly play an important role in motivation and learning. We have recently developed a pair of paradigms to detect a reward related signal in the primary motor cortex, where transcranial magnetic stimulation can be used to measure brief events. So far, we have tested healthy volunteers; we now intend to study Parkinson disease (PD) patients in order to help clarify the role of dopamine in effect of reward. The Parkinson patients will be tested both on and off levodopa/carbidopa and dopamine agonist medications. Our hypothesis is that the dopamine reward related signal will alter level of evocable inhibition in primary motor cortex. Using a behavioral paradigm that deliver intermittent reward, we aim to demonstrate, in treated and untreated PD patients a difference in the amount of cortical inhibition, i) when reward is expected compared to when reward is not expected and ii) after rewarded compared to unrewarded trials. We also aim to demonstrate a difference between their response and that of healthy controls.
- Conditions
- Parkinson Disease
- Keywords
- Disruptive Behavior Disorders, Behavior, Gambling, Dopaminergic Mechanisms, Dopamine, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease, Attention Deficit and Disruptive Behavior Disorders, Behavior, Gambling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study start8 Nov 2007
- Study completion13 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558766
- Sponsor's protocol ID
- 080023
- Other IDs
- 08-N-0023
- Status last verified
- 13 Jun 2011
- First submitted
- 14 Nov 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
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.
PubMed 15221629Cohen 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.
PubMed 16289773Strobel 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.
PubMed 12606846
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Cortex Reward Signaling in Parkinson Disease
- ClinicalTrials.gov ID
- NCT00558766
- Acronym / sponsor ID
- 080023
- Conditions
- Parkinson Disease
- Keywords
- Disruptive Behavior Disorders, Behavior, Gambling, Dopaminergic Mechanisms, Dopamine, Parkinson Disease, PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 8 Nov 2007
- Study completion
- 13 Jun 2011
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
The role of mesencephalic dopamine neurons in reward processing has been established in primates using electrophysiological techniques and in humans using functional neuroimaging. Their role is thought to be dual: i) they show sustained activity with the expectation of a future reward and ii) a phasic response after reward. Animal data indicate that these neurons, located in the midbrain areas A8-10, behave as a single functional unit when activated. They have rich projections to both the prefrontal and motor cortices where they synapse on interneurons and cortical pyramidal cells, producing primarily inhibition. Though their function is not fully understood, these projections clearly play an important role in motivation and learning. We have recently developed a pair of paradigms to detect a reward related signal in the primary motor cortex, where transcranial magnetic stimulation can be used to measure brief events. So far, we have tested healthy volunteers; we now intend to study Parkinson disease (PD) patients in order to help clarify the role of dopamine in effect of reward. The Parkinson patients will be tested both on and off levodopa/carbidopa and dopamine agonist medications. Our hypothesis is that the dopamine reward related signal will alter level of evocable inhibition in primary motor cortex. Using a behavioral paradigm that deliver intermittent reward, we aim to demonstrate, in treated and untreated PD patients a difference in the amount of cortical inhibition, i) when reward is expected compared to when reward is not expected and ii) after rewarded compared to unrewarded trials. We also aim to demonstrate a difference between their response and that of healthy controls.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Age 45-70 years
- Mild-moderate disease (Hoehn and Yahr stage 1-2).
- Age 45-70 yrs
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15221629Avanzi 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.
- Background: PubMed 16289773Cohen 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.
- Background: PubMed 12606846Strobel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00558766, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.