HealthyNCT00885131
Effect of Reward on Learning in Motor Cortex
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to take pictures of the brain. Some MRI studies suggest that this technique reveals brain differences in patients with a nervous system illness when compared to adults without a nervous system illness. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Healthy
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2009to 22 Jan 2013
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50.
- Right handed.
Who cannot join
- Significant neurological or psychiatric history
- 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
- Use of medication affecting the DA system, such as phenothiazine antihistamines (promethazine), antiemetics or decongestants within the last month
- Significant abnormality on neurological examination
- Metal in the cranial cavity or eye, pacemaker, implanted pumps or stimulators
- Subjects who participate in any one experiment in this protocol may not participate in another experiment in this protocol.
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
Official title: Effects of Reward on Learning in the Motor Cortex
Background:
- Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to take pictures of the brain. Some MRI studies suggest that this technique reveals brain differences in patients with a nervous system illness when compared to adults without a nervous system illness.
Read more
Objectives:
- To study functional changes in the brain that may be observed in people without any nervous system illness.
- To learn more about which areas of the brain are necessary to perform certain tasks, especially learning simple motor sequences and processing rewards.
Eligibility:
- Healthy volunteers between the ages of 18 and 50 who are right-handed and are native English speakers, and who have no medical conditions that would prevent them from undergoing magnetic imaging.
- Volunteers must not have a history of neurological or psychiatric illnesses.
- Female volunteers must not be pregnant.
Design:
- Volunteers will be asked to undergo different types of magnetic imaging, including functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS), and/or transcranial magnetic stimulation (TMS), while participating in either a slot machine simulation or a key sequence learning task.
- Volunteers will participate in one of four possible experiments:
- Experiment 1: MRS/TMS and slot machine (3 visits, 3.5 hours in total).
- Experiment 2: MRS/TMS and key sequence (3 visits, 3.5 hours in total).
- Experiment 3: fMRI and slot machine (2 visits, 3 hours in total).
- Experiment 4: fMRI and key sequence (1 visit, 2 hours in total).
- Experiment types:
- Slot machine: A computer game like a slot machine, where the user presses a button to start the game and watches as the three barrels of the machine spin into place.
- Key sequence: Pressing a series of buttons in response to visual cues.
- Volunteers will also be asked to give a small blood sample for genetic testing.
- Volunteers will be paid a small amount of money (approximately $50 $80) during the experiments in compensation for their participation in the study.
Read the detailed description
Objective: The role of mesencephalic dopamine neurons in reward processing has been established in primates using electrophysiological techniques and in humans using functional neuroimaging. 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 recently developed a paradigm to detect reward-related signals in the primary motor cortex, using transcranial magnetic stimulation (TMS), and demonstrated increased inhibition in primary motor cortex under conditions of increased reward expectancy. These results suggest that motor learning, which depends critically on the motor cortex, may be influenced by reward, which may take the form of simple performance feedback in humans. This kind of feedback also allows subjects to predict the outcome of actions. Thus, our present objective is to investigate the influence of reward/feedback/prediction on the activity of primary motor cortex during motor learning and in particular during instances of increased reward expectancy. Further, we will examine the role of a brain derived neurotrophic factor (BDNF) single nucleotide polymorphism on motor learning.
Study Population: The population that we will study will be healthy volunteers between the ages of 18-50, without any significant medical history or contraindication to functional magnetic resonance imaging (fMRI).
Design: All experiments will employ within- or between-subjects fMRI and magnetic resonance spectroscopy (MRS) to measure changes in activations of different cortical areas in response to motor learning and reward.
Outcome Measures: The outcome measures will be (a) graded changes in blood oxygen level-dependent (BOLD) in response to motor learning and reward and (b) variations in GABA concentration in response to motor learning and reward, and c) variations in response time in the behavioral performance of a learning task.
- Conditions
- Healthy
- Keywords
- Reward Processing, Motor Cortex, HV, Healthy Volunteer
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measures will be (a) graded changes in blood oxygen level-dependent (BOLD) in response to motor learning and reward and (b) variations in GABA concentration in response to motor learning and reward.
Secondary outcomes (1)
The secondary outcome measures will be variations in response time in the behavioral performance of a learning task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study start15 Apr 2009
- Study completion22 Jan 2013
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 HealthyStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- United States Department of Defense, National Institutes of Health Clinical Center (CC), Center for Neuroscience and Regenerative Medicine (CNRM)
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885131
- Sponsor's protocol ID
- 090124
- Other IDs
- 09-N-0124
- Status last verified
- 22 Jan 2013
- First submitted
- 18 Apr 2009
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Arancio O, Chao MV. Neurotrophins, synaptic plasticity and dementia. Curr Opin Neurobiol. 2007 Jun;17(3):325-30. doi: 10.1016/j.conb.2007.03.013. Epub 2007 Apr 6.
PubMed 17419049Ashe J, Lungu OV, Basford AT, Lu X. Cortical control of motor sequences. Curr Opin Neurobiol. 2006 Apr;16(2):213-21. doi: 10.1016/j.conb.2006.03.008. Epub 2006 Mar 24.
PubMed 16563734Avanzi 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 15221629
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reward on Learning in the Motor Cortex
- ClinicalTrials.gov ID
- NCT00885131
- Acronym / sponsor ID
- 090124
- Conditions
- Healthy
- Keywords
- Reward Processing, Motor Cortex, HV, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- United States Department of Defense, National Institutes of Health Clinical Center (CC), Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 15 Apr 2009
- Study completion
- 22 Jan 2013
- First posted
- 21 Apr 2009 (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:
- Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to take pictures of the brain. Some MRI studies suggest that this technique reveals brain differences in patients with a nervous system illness when compared to adults without a nervous system illness.
Objectives:
- To study functional changes in the brain that may be observed in people without any nervous system illness.
- To learn more about which areas of the brain are necessary to perform certain tasks, especially learning simple motor sequences and processing rewards.
Eligibility:
- Healthy volunteers between the ages of 18 and 50 who are right-handed and are native English speakers, and who have no medical conditions that would prevent them from undergoing magnetic imaging.
- Volunteers must not have a history of neurological or psychiatric illnesses.
- Female volunteers must not be pregnant.
Design:
- Volunteers will be asked to undergo different types of magnetic imaging, including functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS), and/or transcranial magnetic stimulation (TMS), while participating in either a slot machine simulation or a key sequence learning task.
- Volunteers will participate in one of four possible experiments:
- Experiment 1: MRS/TMS and slot machine (3 visits, 3.5 hours in total).
- Experiment 2: MRS/TMS and key sequence (3 visits, 3.5 hours in total).
- Experiment 3: fMRI and slot machine (2 visits, 3 hours in total).
- Experiment 4: fMRI and key sequence (1 visit, 2 hours in total).
- Experiment types:
- Slot machine: A computer game like a slot machine, where the user presses a button to start the game and watches as the three barrels of the machine spin into place.
- Key sequence: Pressing a series of buttons in response to visual cues.
- Volunteers will also be asked to give a small blood sample for genetic testing.
- Volunteers will be paid a small amount of money (approximately $50 $80) during the experiments in compensation for their participation in the study.
Detailed description
Objective: The role of mesencephalic dopamine neurons in reward processing has been established in primates using electrophysiological techniques and in humans using functional neuroimaging. 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 recently developed a paradigm to detect reward-related signals in the primary motor cortex, using transcranial magnetic stimulation (TMS), and demonstrated increased inhibition in primary motor cortex under conditions of increased reward expectancy. These results suggest that motor learning, which depends critically on the motor cortex, may be influenced by reward, which may take the form of simple performance feedback in humans. This kind of feedback also allows subjects to predict the outcome of actions. Thus, our present objective is to investigate the influence of reward/feedback/prediction on the activity of primary motor cortex during motor learning and in particular during instances of increased reward expectancy. Further, we will examine the role of a brain derived neurotrophic factor (BDNF) single nucleotide polymorphism on motor learning.
Study Population: The population that we will study will be healthy volunteers between the ages of 18-50, without any significant medical history or contraindication to functional magnetic resonance imaging (fMRI).
Design: All experiments will employ within- or between-subjects fMRI and magnetic resonance spectroscopy (MRS) to measure changes in activations of different cortical areas in response to motor learning and reward.
Outcome Measures: The outcome measures will be (a) graded changes in blood oxygen level-dependent (BOLD) in response to motor learning and reward and (b) variations in GABA concentration in response to motor learning and reward, and c) variations in response time in the behavioral performance of a learning task.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50.
- Right handed.
Key exclusion criteria (6 listed)
- Significant neurological or psychiatric history
- 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
- Use of medication affecting the DA system, such as phenothiazine antihistamines (promethazine), antiemetics or decongestants within the last month
- Significant abnormality on neurological examination
- Metal in the cranial cavity or eye, pacemaker, implanted pumps or stimulators
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
The outcome measures will be (a) graded changes in blood oxygen level-dependent (BOLD) in response to motor learning and reward and (b) variations in GABA concentration in response to motor learning and reward.
1 secondary outcome
The secondary outcome measures will be variations in response time in the behavioral performance of a learning task.
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 9 Dec 2019.
- Background: PubMed 17419049Arancio O, Chao MV. Neurotrophins, synaptic plasticity and dementia. Curr Opin Neurobiol. 2007 Jun;17(3):325-30. doi: 10.1016/j.conb.2007.03.013. Epub 2007 Apr 6.
- Background: PubMed 16563734Ashe J, Lungu OV, Basford AT, Lu X. Cortical control of motor sequences. Curr Opin Neurobiol. 2006 Apr;16(2):213-21. doi: 10.1016/j.conb.2006.03.008. Epub 2006 Mar 24.
- 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.
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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.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Healthy, 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 2 inclusion and 6 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 9 Dec 2019. 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.
What does the primary outcome measure?
The outcome measures will be (a) graded changes in blood oxygen level-dependent (BOLD) in response to motor learning and reward and (b) variations in GABA concentration in response to motor learning and reward.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885131, 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 9 Dec 2019.