HealthyNCT00061334
Investigating the Cognitive Processes That Underlie Social Knowledge and Behavior
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2003to 29 Dec 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The healthy normal controls recruited into these studies will be determined by Section staff phone and in-person interviews to be free of psychiatric, neurological, or other medical disorders that would constrain interpretation of their performance during functional neuroimaging studies. In addition, all normal volunteers must undergo a neuroexam performed by the medically responsible investigator, an NINDS physician, once a year before undergoing MRI scanning. The neurological exam will be done in the neurology outpatient clinic.
- All subjects will be native English-speakers and right-handed, as measured by the Edinburgh Handedness Inventory, due to the association between language lateralization and handedness.
- In addition, all subjects in Study 3 (that addresses political stereotypes) will be American and will be screened for political affiliation using several measures prior to participation in the study.
- Political affiliation will be assessed by obtaining (1) self-reported political orientation of the subject on a scale of 1 to 7 (where 1 is extremely liberal and 7 is extremely conservative, Wyer et al., 1991), (2) political party preference of the subject on a scale of 1 to 7 (where 1 is strongly Democratic and 7 is strongly Republican, Wyer et al., 1991), and (3) scores on the Conservatism-Liberalism Scale (Mehrabian, 1996). Subjects rating their orientation and preference (measures 1 and 2) as 3 or lower or 5 or higher and also scoring higher than 20 or lower than -20 (maximum scores are plus or minus 28) on the Conservatism-Liberalism Scale will be included in the study. American citizenship and the political screening is necessary to enable the classification of conditions as stereotype-congruent and - incongruent (as this is determined by their status as 'Democrat' or 'Republican'). Subjects in Study 4 (that addresses political psychological structures) will be screened to be American citizens prior to participating to the study. Party affiliation, political orientation and adjunctive demographical data will be collected at the end of the fMRI scan to be eventually considered as a potential source of variability in the statistical analysis.
Who cannot join
- Individuals with a neurological or psychiatric history or medical condition that would compromise our interpretation of the fMRI results will be excluded.
- Exclusion criteria are: medical contraindications to MRI procedures (e.g. pacemakers, cochlear devices, surgical clips); technical contraindications to MRI procedures (e.g. no braces); CNS active medications; and claustrophobia.
- Pregnant women will also be excluded from participation due to the unknown effects of the high magnetic field on a developing fetus; to ensure compliance with this criterion, all women will undergo a pregnancy test within 24 hours prior to the scan. The results of the pregnancy test must be negative in order for the women to be scanned.
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: Social Knowledge Representation in the Human Prefrontal Cortex
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 and ventromedial prefrontal cortex in social cognition and emotional processing. We will ascertain the relationship between so-called cold cognition such as event knowledge and "hot" social cognition such as attitude formation and specific brain regions within the prefrontal cortex. We will also attempt to determine the relationship between non-frontal neural structures involved in emotional expressions, such as amygdala, and those frontal neural structures involved in executive functions that may modulate emotion. The data that we collect in this protocol will be of value in (1) identifying a set of neural regions and distributed networks mediating the forms of knowledge representation stored in the prefrontal cortex and (2) developing functional MRI screening measures for subjects at-risk for developing a neurological disorder. We will also use the data obtained in these studies with healthy adult volunteers to constrain theories of frontal lobe function based on the study of patients with focal or diffuse frontal lobe lesions and to provide convergent evidence for the role of specific frontal cortex sectors in specific cognitive functions.
Read the detailed description
Objective
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. We suspect that political attitudes can also be viewed as a type of stored knowledge. Religious attitudinal and event knowledge are also expected to be similarly represented and stored. Utilizing a variety of experimental neuropsychological tasks during functional MRI, we will investigate hypotheses regarding the role of the dorsolateral and ventromedial prefrontal cortex in social cognition and emotional processing. We will ascertain the relationship between so-called "cold" cognition such as event knowledge and "hot" social cognition such as attitude formation and specific brain regions within the prefrontal cortex.
Study Population
Normal adult volunteers will participate in experiments dealing with processing of event knowledge, general attitudes, political stereotypes and attitudes, and religious attitudes, using fMRI.
Design
All the experiments will employ within-subject event-related fMRI design to determine whether activations of different cortical areas correspond to different kind of stored knowledge.
Outcome Measures
The data that we collect in this protocol will consist of fMRI activation images corresponding to varying neuropsychological tasks. The will be of value in (1) identifying a set of neural regions and distributed networks mediating the forms of knowledge representation stored in the prefrontal cortex and (2) developing functional MRI screening measures for subjects at-risk for developing a neurological disorder.
- Conditions
- Healthy
- Keywords
- Attitudes, fMRI, Development, Stereotypes, Memory, Healthy Volunteer, HV
- Medical subject headings
- Behavior, Stereotypic Movement Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2003 (estimated)
- Study start7 May 2003
- Study completion29 Dec 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 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
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061334
- Sponsor's protocol ID
- 030196
- Other IDs
- 03-N-0196
- Status last verified
- 29 Dec 2011
- First submitted
- 23 May 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Cordes D, Turski PA, Sorenson JA. Compensation of susceptibility-induced signal loss in echo-planar imaging for functional applications. Magn Reson Imaging. 2000 Nov;18(9):1055-68. doi: 10.1016/s0730-725x(00)00199-5.
PubMed 11118760Deichmann R, Josephs O, Hutton C, Corfield DR, Turner R. Compensation of susceptibility-induced BOLD sensitivity losses in echo-planar fMRI imaging. Neuroimage. 2002 Jan;15(1):120-35. doi: 10.1006/nimg.2001.0985.
PubMed 11771980Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. doi: 10.1016/s0165-0270(02)00121-8.
PubMed 12204303
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
- Social Knowledge Representation in the Human Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT00061334
- Acronym / sponsor ID
- 030196
- Conditions
- Healthy
- Keywords
- Attitudes, fMRI, Development, Stereotypes, Memory, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 7 May 2003
- Study completion
- 29 Dec 2011
- First posted
- 26 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.
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 and ventromedial prefrontal cortex in social cognition and emotional processing. We will ascertain the relationship between so-called cold cognition such as event knowledge and "hot" social cognition such as attitude formation and specific brain regions within the prefrontal cortex. We will also attempt to determine the relationship between non-frontal neural structures involved in emotional expressions, such as amygdala, and those frontal neural structures involved in executive functions that may modulate emotion. The data that we collect in this protocol will be of value in (1) identifying a set of neural regions and distributed networks mediating the forms of knowledge representation stored in the prefrontal cortex and (2) developing functional MRI screening measures for subjects at-risk for developing a neurological disorder. We will also use the data obtained in these studies with healthy adult volunteers to constrain theories of frontal lobe function based on the study of patients with focal or diffuse frontal lobe lesions and to provide convergent evidence for the role of specific frontal cortex sectors in specific cognitive functions.
Detailed description
Objective
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. We suspect that political attitudes can also be viewed as a type of stored knowledge. Religious attitudinal and event knowledge are also expected to be similarly represented and stored. Utilizing a variety of experimental neuropsychological tasks during functional MRI, we will investigate hypotheses regarding the role of the dorsolateral and ventromedial prefrontal cortex in social cognition and emotional processing. We will ascertain the relationship between so-called "cold" cognition such as event knowledge and "hot" social cognition such as attitude formation and specific brain regions within the prefrontal cortex.
Study Population
Normal adult volunteers will participate in experiments dealing with processing of event knowledge, general attitudes, political stereotypes and attitudes, and religious attitudes, using fMRI.
Design
All the experiments will employ within-subject event-related fMRI design to determine whether activations of different cortical areas correspond to different kind of stored knowledge.
Outcome Measures
The data that we collect in this protocol will consist of fMRI activation images corresponding to varying neuropsychological tasks. The will be of value in (1) identifying a set of neural regions and distributed networks mediating the forms of knowledge representation stored in the prefrontal cortex and (2) developing functional MRI screening measures for subjects at-risk for developing a neurological disorder.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The healthy normal controls recruited into these studies will be determined by Section staff phone and in-person interviews to be free of psychiatric, neurological, or other medical disorders that would constrain interpretation of their performance during functional neuroimaging studies. In addition, all normal volunteers must undergo a neuroexam performed by the medically responsible investigator, an NINDS physician, once a year before undergoing MRI scanning. The neurological exam will be done in the neurology outpatient clinic.
- All subjects will be native English-speakers and right-handed, as measured by the Edinburgh Handedness Inventory, due to the association between language lateralization and handedness.
- In addition, all subjects in Study 3 (that addresses political stereotypes) will be American and will be screened for political affiliation using several measures prior to participation in the study.
- Political affiliation will be assessed by obtaining (1) self-reported political orientation of the subject on a scale of 1 to 7 (where 1 is extremely liberal and 7 is extremely conservative, Wyer et al., 1991), (2) political party preference of the subject on a scale of 1 to 7 (where 1 is strongly Democratic and 7 is strongly Republican, Wyer et al., 1991), and (3) scores on the Conservatism-Liberalism Scale (Mehrabian, 1996). Subjects rating their orientation and preference (measures 1 and 2) as 3 or lower or 5 or higher and also scoring higher than 20 or lower than -20 (maximum scores are plus or minus 28) on the Conservatism-Liberalism Scale will be included in the study. American citizenship and the political screening is necessary to enable the classification of conditions as stereotype-congruent and - incongruent (as this is determined by their status as 'Democrat' or 'Republican'). Subjects in Study 4 (that addresses political psychological structures) will be screened to be American citizens prior to participating to the study. Party affiliation, political orientation and adjunctive demographical data will be collected at the end of the fMRI scan to be eventually considered as a potential source of variability in the statistical analysis.
Key exclusion criteria (3 listed)
- Individuals with a neurological or psychiatric history or medical condition that would compromise our interpretation of the fMRI results will be excluded.
- Exclusion criteria are: medical contraindications to MRI procedures (e.g. pacemakers, cochlear devices, surgical clips); technical contraindications to MRI procedures (e.g. no braces); CNS active medications; and claustrophobia.
- Pregnant women will also be excluded from participation due to the unknown effects of the high magnetic field on a developing fetus; to ensure compliance with this criterion, all women will undergo a pregnancy test within 24 hours prior to the scan. The results of the pregnancy test must be negative in order for the women to be scanned.
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 11118760Cordes D, Turski PA, Sorenson JA. Compensation of susceptibility-induced signal loss in echo-planar imaging for functional applications. Magn Reson Imaging. 2000 Nov;18(9):1055-68. doi: 10.1016/s0730-725x(00)00199-5.
- Background: PubMed 11771980Deichmann R, Josephs O, Hutton C, Corfield DR, Turner R. Compensation of susceptibility-induced BOLD sensitivity losses in echo-planar fMRI imaging. Neuroimage. 2002 Jan;15(1):120-35. doi: 10.1006/nimg.2001.0985.
- Background: PubMed 12204303Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. doi: 10.1016/s0165-0270(02)00121-8.
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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 4 inclusion and 3 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 NCT00061334, 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.