HealthyNCT00060853
Magnetic Resonance Imaging of the Brain in Social and Emotional Reasoning
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use magnetic resonance imaging (MRI) to identify brain regions involved in social and emotional reasoning. It will identify differences in brain activity during task performance between people who have a nervous system illness and those who do not. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- In all the studies, subjects will consist of healthy, native English-speaking, right-handed volunteers, as measured by the Edinburgh Handedness Inventory. Subjects will range in age from 21 to 55 years old and they will be included regardless of race.
- In studies 4 and 5, equal numbers of males and females will be recruited owing to previous findings of significant sex differences on such tests. In all other studies subjects will be recruited indiscriminately on the basis of sex.
Who cannot join
- Non-native English speakers and non-right handers will be excluded as mentioned above, as will non-neurologically normal volunteers. Subjects younger than 21 and older than 55 will be excluded. A pregnancy test will be employed with all women of childbearing age. The results must be negative in order to proceed with the MRI.
- Subjects with any of the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, e.g. metal shavings; insulin pump; or irremovable body piercing will be excluded from the study due to the possible dangerous effects of the magnet upon metal objects in the body.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Reasoning About Social and Economic Knowledge: Identifying the Role of the Human Prefrontal Cortex Using Functional Neuroimaging
This study will use magnetic resonance imaging (MRI) to identify brain regions involved in social and emotional reasoning. It will identify differences in brain activity during task performance between people who have a nervous system illness and those who do not. MRI is a diagnostic tool that uses a strong magnetic field and radio waves to produce images of structural and chemical changes in the brain.
Healthy normal volunteers between 21 and 55 years of age who are right-handed and are native English speakers may be eligible for this study. Candidates will be screened with a medical history, including psychiatric and neurological information.
Participants will be asked to perform social and emotional reasoning tasks, such as sorting and judging rules and rule violations, while undergoing MRI scanning. Some tasks may simply involve viewing items on a screen. Others may involve solving complex problems and responding by pressing buttons. During the scan, the subject lies on a table in a narrow cylinder (the scanner) containing a magnetic field. The scan will last about 2 hours, with subjects asked to lie still for up to 10 minutes at a time.
Read the detailed description
The purpose of the protocol is to localize the neural regions and systems mediating the forms of knowledge representations hypothesized by the principal investigator to be stored in the human prefrontal cortex. Utilizing a variety of experimental neuropsychological tasks during functional MRI, we will investigate hypotheses regarding the role of the dorsolateral prefrontal cortex in planning, problem solving, economic exchange and reasoning; and the role of ventromedial prefrontal cortex in social cognition and emotional processing. We will ascertain the relationship between so-called [cold] cognitive processes such as planning and [hot] social processes such as mate choice and specific brain regions within the prefrontal cortex. We will also attempt to determine the relationship between non-frontal neural structures involved in emotional expression, such as the amygdala, and those frontal neural structures involved in executive functions that may modulate emotion. In addition, we will attempt to determine the requirements for frontal-parietal versus frontal-temporal network involvement in spatial landmark tasks. The data that we collect in this protocol will be of value in identifying a set of neural regions and distributed networks mediating the forms of knowledge representation stored in the prefrontal cortex. These questions will be addressed over seven separate studies with healthy, normal adult volunteers. The studies will employ within- and between-subject, event-related fMRI designs. The data collected will consist of behavioral measures of cognitive and emotional performance/judgment and corresponding fMRI images.
- Conditions
- Healthy
- Keywords
- Amygdala, Orbitofrontal Cortex, Emotion, Cognition, Theory of Mind, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2003 (estimated)
- Study startMay 2003
- Study completionMay 2005
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.
- 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
- Enrolment
- 330 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060853
- Sponsor's protocol ID
- 030197
- Other IDs
- 03-N-0197
- Status last verified
- May 2005
- First submitted
- 14 May 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
PubMed 1948051Belliveau JW, Rosen BR, Kantor HL, Rzedzian RR, Kennedy DN, McKinstry RC, Vevea JM, Cohen MS, Pykett IL, Brady TJ. Functional cerebral imaging by susceptibility-contrast NMR. Magn Reson Med. 1990 Jun;14(3):538-46. doi: 10.1002/mrm.1910140311.
PubMed 2355835Bergeron C, Pollanen MS, Weyer L, Lang AE. Cortical degeneration in progressive supranuclear palsy. A comparison with cortical-basal ganglionic degeneration. J Neuropathol Exp Neurol. 1997 Jun;56(6):726-34.
PubMed 9184663
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasoning About Social and Economic Knowledge: Identifying the Role of the Human Prefrontal Cortex Using Functional Neuroimaging
- ClinicalTrials.gov ID
- NCT00060853
- Acronym / sponsor ID
- 030197
- Conditions
- Healthy
- Keywords
- Amygdala, Orbitofrontal Cortex, Emotion, Cognition, Theory of Mind, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 2003
- Study completion
- May 2005
- First posted
- 14 May 2003 (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.
This study will use magnetic resonance imaging (MRI) to identify brain regions involved in social and emotional reasoning. It will identify differences in brain activity during task performance between people who have a nervous system illness and those who do not. MRI is a diagnostic tool that uses a strong magnetic field and radio waves to produce images of structural and chemical changes in the brain.
Healthy normal volunteers between 21 and 55 years of age who are right-handed and are native English speakers may be eligible for this study. Candidates will be screened with a medical history, including psychiatric and neurological information.
Participants will be asked to perform social and emotional reasoning tasks, such as sorting and judging rules and rule violations, while undergoing MRI scanning. Some tasks may simply involve viewing items on a screen. Others may involve solving complex problems and responding by pressing buttons. During the scan, the subject lies on a table in a narrow cylinder (the scanner) containing a magnetic field. The scan will last about 2 hours, with subjects asked to lie still for up to 10 minutes at a time.
Detailed description
The purpose of the protocol is to localize the neural regions and systems mediating the forms of knowledge representations hypothesized by the principal investigator to be stored in the human prefrontal cortex. Utilizing a variety of experimental neuropsychological tasks during functional MRI, we will investigate hypotheses regarding the role of the dorsolateral prefrontal cortex in planning, problem solving, economic exchange and reasoning; and the role of ventromedial prefrontal cortex in social cognition and emotional processing. We will ascertain the relationship between so-called [cold] cognitive processes such as planning and [hot] social processes such as mate choice and specific brain regions within the prefrontal cortex. We will also attempt to determine the relationship between non-frontal neural structures involved in emotional expression, such as the amygdala, and those frontal neural structures involved in executive functions that may modulate emotion. In addition, we will attempt to determine the requirements for frontal-parietal versus frontal-temporal network involvement in spatial landmark tasks. The data that we collect in this protocol will be of value in identifying a set of neural regions and distributed networks mediating the forms of knowledge representation stored in the prefrontal cortex. These questions will be addressed over seven separate studies with healthy, normal adult volunteers. The studies will employ within- and between-subject, event-related fMRI designs. The data collected will consist of behavioral measures of cognitive and emotional performance/judgment and corresponding fMRI images.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- In all the studies, subjects will consist of healthy, native English-speaking, right-handed volunteers, as measured by the Edinburgh Handedness Inventory. Subjects will range in age from 21 to 55 years old and they will be included regardless of race.
- In studies 4 and 5, equal numbers of males and females will be recruited owing to previous findings of significant sex differences on such tests. In all other studies subjects will be recruited indiscriminately on the basis of sex.
Key exclusion criteria (2 listed)
- Non-native English speakers and non-right handers will be excluded as mentioned above, as will non-neurologically normal volunteers. Subjects younger than 21 and older than 55 will be excluded. A pregnancy test will be employed with all women of childbearing age. The results must be negative in order to proceed with the MRI.
- Subjects with any of the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, e.g. metal shavings; insulin pump; or irremovable body piercing will be excluded from the study due to the possible dangerous effects of the magnet upon metal objects in the body.
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 4 Mar 2008.
- Background: PubMed 1948051Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
- Background: PubMed 2355835Belliveau JW, Rosen BR, Kantor HL, Rzedzian RR, Kennedy DN, McKinstry RC, Vevea JM, Cohen MS, Pykett IL, Brady TJ. Functional cerebral imaging by susceptibility-contrast NMR. Magn Reson Med. 1990 Jun;14(3):538-46. doi: 10.1002/mrm.1910140311.
- Background: PubMed 9184663Bergeron C, Pollanen MS, Weyer L, Lang AE. Cortical degeneration in progressive supranuclear palsy. A comparison with cortical-basal ganglionic degeneration. J Neuropathol Exp Neurol. 1997 Jun;56(6):726-34.
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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 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 2 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 4 Mar 2008. 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 NCT00060853, 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 4 Mar 2008.