HealthyNCT00076739
Study of Brain Function During Cognitive Tasks
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 examine which areas of the brain are involved in performing certain cognitive tasks. MRI uses a strong magnetic field and radio waves to produce images of body tissues and organs that provide information about structure and function of tissues. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2004to 12 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 40 years
- All sexes
- Healthy volunteers accepted
- 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 40 years old and they will be included regardless of race or gender.
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 40 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; permanent eyeliner; 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.
- Subjects taking central nervous system active medications will be excluded.
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: Examining Associative Relations in Structured Event Complexes Using Functional Neuroimaging
This study will use magnetic resonance imaging (MRI) to examine which areas of the brain are involved in performing certain cognitive tasks. MRI uses a strong magnetic field and radio waves to produce images of body tissues and organs that provide information about structure and function of tissues.
Healthy normal volunteers between 21 and 40 years of age may be eligible for this study. Candidates must be native English speakers and must be right-handed. They must have no history of nervous system disease or psychiatric disorder. Candidates are screened with questionnaires and a neurological examination.
Read more
Participants undergo functional MRI scanning. For this procedure, the subject lies on a stretcher that moves into the scanner - a metal cylinder surrounded by a strong magnetic field. During the scan, he or she is asked to make various decisions about whether words are related or not. Two words are presented visually, separated by a variable time delay. The subject reads both words, decides as quickly and accurately as possible whether the two words are related or not, and indicates the answer by pressing a button. The test takes about 2 hours. When it is completed, the subject completes a written questionnaire concerning his or her experience in the scanner.
...
Read the detailed description
Objective. The purpose of the protocol is to extend the structured event complex (SEC) model developed by the principal investigator. Grafman (Grafman, 1995) proposed that action sequences are represented in form of SECs in the human prefrontal cortex (PFC). An SEC is a goal-oriented set of events that is sequentially structured and represents thematic knowledge, morals, abstractions, concepts, social rules, event features, event boundaries, and grammars. There are both temporal and semantic associative relations between subcomponents of SEC knowledge. We will investigate hypotheses regarding the role of different regions within the PFC in processing associative relations. We will also investigate how SECs differing in psychological dimensions such as temporal duration, complexity, and familiarity are represented and activated in the PFC. We will further examine the temporal and semantic organization of SEC subcomponents by investigating how the goal and outcome structure of event knowledge is represented and activated in the PFC. Further, we will investigate how the temporal location of events within SECs are represented and activated in the PFC. We will also investigate how goals and outcomes specifying the temporal order and duration of SEC subcomponents are processed within the PFC. Additional objectives are to (1) investigate the neural representation of human emotions and decision-making based on utility estimation; (2) investigate the relationships between cognitive and neural substrates of moral emotions and judgment (Moll et al., 2002a; Moll et al., 2002b) with those of the SEC model developed by the principal investigator (Grafman, 1995); and (3) probe a new construct of cognitive dimensions incorporating critical explanatory variables in social cognition such as moral emotions and social event knowledge.
Study Population. In nineteen separate studies, healthy, normal adult volunteers will participate in experiments dealing with different kinds of associative relations in SECs using functional magnetic resonance imaging (fMRI).
Design. The experiments we are conducting will employ within-subject, rapid event-related fMRI designs to determine whether different types of SEC associative and other types of relations are stored in dissociable networks in the PFC. In nineteen experiments; we hope to automatically activate lexical, event-based and temporally-based associative and other types of relations in SECs.
Outcome Measures. The data collected will consist of accuracy and response time measures of cognitive performance reflecting automatic priming of associative relations and fMRI activation images corresponding to each kind of associative relation, and accuracy and response time measures of cognitive performance reflecting how temporal duration, complexity, and familiarity are represented and activated. Experiments 10 and 11 will also record donation choices made by the subjects. The results gained from this protocol will provide further evidence for modifying, supporting, or rejecting aspects of the SEC model, and will provide further evidence for modifying, supporting, or rejecting aspects of a framework of social cognition such as moral behavior and social event knowledge.
- Conditions
- Healthy
- Keywords
- Prefrontal Cortex, Semantic Memory, Semantic Relations, Priming Paradigm, fMRI, 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 posted3 Feb 2004 (estimated)
- Study start2 Feb 2004
- Study completion12 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
- 452 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
- NCT00076739
- Sponsor's protocol ID
- 040113
- Other IDs
- 04-N-0113
- Status last verified
- 12 Dec 2011
- First submitted
- 2 Feb 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Abernethy M, Coney J. Semantic category priming in the left cerebral hemisphere. Neuropsychologia. 1996 May;34(5):339-50. doi: 10.1016/0028-3932(95)00144-1.
PubMed 9148190Belliveau 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 2355835
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
- Examining Associative Relations in Structured Event Complexes Using Functional Neuroimaging
- ClinicalTrials.gov ID
- NCT00076739
- Acronym / sponsor ID
- 040113
- Conditions
- Healthy
- Keywords
- Prefrontal Cortex, Semantic Memory, Semantic Relations, Priming Paradigm, fMRI, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 2 Feb 2004
- Study completion
- 12 Dec 2011
- First posted
- 3 Feb 2004 (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 examine which areas of the brain are involved in performing certain cognitive tasks. MRI uses a strong magnetic field and radio waves to produce images of body tissues and organs that provide information about structure and function of tissues.
Healthy normal volunteers between 21 and 40 years of age may be eligible for this study. Candidates must be native English speakers and must be right-handed. They must have no history of nervous system disease or psychiatric disorder. Candidates are screened with questionnaires and a neurological examination.
Participants undergo functional MRI scanning. For this procedure, the subject lies on a stretcher that moves into the scanner - a metal cylinder surrounded by a strong magnetic field. During the scan, he or she is asked to make various decisions about whether words are related or not. Two words are presented visually, separated by a variable time delay. The subject reads both words, decides as quickly and accurately as possible whether the two words are related or not, and indicates the answer by pressing a button. The test takes about 2 hours. When it is completed, the subject completes a written questionnaire concerning his or her experience in the scanner.
...
Detailed description
Objective. The purpose of the protocol is to extend the structured event complex (SEC) model developed by the principal investigator. Grafman (Grafman, 1995) proposed that action sequences are represented in form of SECs in the human prefrontal cortex (PFC). An SEC is a goal-oriented set of events that is sequentially structured and represents thematic knowledge, morals, abstractions, concepts, social rules, event features, event boundaries, and grammars. There are both temporal and semantic associative relations between subcomponents of SEC knowledge. We will investigate hypotheses regarding the role of different regions within the PFC in processing associative relations. We will also investigate how SECs differing in psychological dimensions such as temporal duration, complexity, and familiarity are represented and activated in the PFC. We will further examine the temporal and semantic organization of SEC subcomponents by investigating how the goal and outcome structure of event knowledge is represented and activated in the PFC. Further, we will investigate how the temporal location of events within SECs are represented and activated in the PFC. We will also investigate how goals and outcomes specifying the temporal order and duration of SEC subcomponents are processed within the PFC. Additional objectives are to (1) investigate the neural representation of human emotions and decision-making based on utility estimation; (2) investigate the relationships between cognitive and neural substrates of moral emotions and judgment (Moll et al., 2002a; Moll et al., 2002b) with those of the SEC model developed by the principal investigator (Grafman, 1995); and (3) probe a new construct of cognitive dimensions incorporating critical explanatory variables in social cognition such as moral emotions and social event knowledge.
Study Population. In nineteen separate studies, healthy, normal adult volunteers will participate in experiments dealing with different kinds of associative relations in SECs using functional magnetic resonance imaging (fMRI).
Design. The experiments we are conducting will employ within-subject, rapid event-related fMRI designs to determine whether different types of SEC associative and other types of relations are stored in dissociable networks in the PFC. In nineteen experiments; we hope to automatically activate lexical, event-based and temporally-based associative and other types of relations in SECs.
Outcome Measures. The data collected will consist of accuracy and response time measures of cognitive performance reflecting automatic priming of associative relations and fMRI activation images corresponding to each kind of associative relation, and accuracy and response time measures of cognitive performance reflecting how temporal duration, complexity, and familiarity are represented and activated. Experiments 10 and 11 will also record donation choices made by the subjects. The results gained from this protocol will provide further evidence for modifying, supporting, or rejecting aspects of the SEC model, and will provide further evidence for modifying, supporting, or rejecting aspects of a framework of social cognition such as moral behavior and social event knowledge.
Study design
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 40 years old and they will be included regardless of race or gender.
Key exclusion criteria (5 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 40 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; permanent eyeliner; 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.
- Subjects taking central nervous system active medications will be excluded.
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 9148190Abernethy M, Coney J. Semantic category priming in the left cerebral hemisphere. Neuropsychologia. 1996 May;34(5):339-50. doi: 10.1016/0028-3932(95)00144-1.
- 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.
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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 5 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 NCT00076739, 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.