HealthyNCT00061204
Magnetic Resonance Imaging of the Brain in Emotional Processing
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 performing certain tasks, especially those involving emotions. 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Apr 2006
- 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
- The study population will consist of young healthy volunteers.
- Age range: 18 to 40
- Right-handedness (some left-handed subjects may be recruited for preliminary behavioral studies)
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.
- Individuals with a current or past history of post-traumatic stress disorder or other psychiatric disorder or individuals with a history of physical or sexual abuse will be excluded as they may be disturbed by viewing graphic pictures.
- Subjects with contraindications to exposure to high magnetic field.
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: Functional Neuroimaging of Social Cognitive and Emotional Processing: Technical and Cognitive Issues
This study will use magnetic resonance imaging (MRI) to identify brain regions involved in performing certain tasks, especially those involving emotions. 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. The study will also examine which MRI techniques are best to use when scanning brain areas involved in different emotions.
Healthy normal volunteers between 18 and 40 years of age who are right-handed and are native English speakers may be eligible for this study. Individuals with a history of neurological disease, post-traumatic stress disorder or other psychiatric disorder, or who have a history of physical or sexual abuse may not participate. Candidates will be screened with a written questionnaire and a medical history, including psychiatric and neurological information.
Participants will perform tasks involving emotions while undergoing MRI scanning. For this procedure, the subject lies on a table in a narrow metal cylinder (the scanner) containing a magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. The subject is asked to lie still for up to 10 minutes at a time. During the scan, the subject performs simple tasks involving the viewing of pictures on a screen. Other tasks involve viewing pictures and responding to them by pressing buttons. Some pictures are violent or pornographic, while others are pleasant to view. Of a total of 162 pictures, 30 percent are categorized as graphic and possibly disturbing.
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 experimental neuropsychological tasks during functional MRI on healthy adult volunteers, we will investigate hypotheses regarding the role of the ventromedial prefrontal cortex in social cognition and emotional processing as opposed to the dorsolateral prefrontal cortex, involved in nonsocial-events (planning, problem solving, economic exchange and reasoning). 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. Another goal of our study is to test different fMRI sequences to determine which one gives us the best quality of signal in the amygdala and orbitofrontal cortex (affected by signal drop-out due to magnetic susceptibility artifacts). 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) contributing to optimization of functional imaging of the amygdala and orbitofrontal cortex at high field strength (3 Tesla). We will also use the data obtained in these studies to constrain theories of frontal lobe function and to provide evidence for the role of specific frontal cortex sectors in specific cognitive functions.
- Conditions
- Healthy
- Keywords
- fMRI, Susceptibility Artifacts, Prefrontal Cortex, Temporal Lobes, Methodology, 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 posted22 May 2003 (estimated)
- Study startMay 2003
- Study completionApr 2006
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
- 38 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061204
- Sponsor's protocol ID
- 030195
- Other IDs
- 03-N-0195
- Status last verified
- Apr 2006
- First submitted
- 21 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 2355835Bodner M, Kroger J, Fuster JM. Auditory memory cells in dorsolateral prefrontal cortex. Neuroreport. 1996 Aug 12;7(12):1905-8. doi: 10.1097/00001756-199608120-00006.
PubMed 8905689
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
- Functional Neuroimaging of Social Cognitive and Emotional Processing: Technical and Cognitive Issues
- ClinicalTrials.gov ID
- NCT00061204
- Acronym / sponsor ID
- 030195
- Conditions
- Healthy
- Keywords
- fMRI, Susceptibility Artifacts, Prefrontal Cortex, Temporal Lobes, Methodology, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 2003
- Study completion
- Apr 2006
- First posted
- 22 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 performing certain tasks, especially those involving emotions. 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. The study will also examine which MRI techniques are best to use when scanning brain areas involved in different emotions.
Healthy normal volunteers between 18 and 40 years of age who are right-handed and are native English speakers may be eligible for this study. Individuals with a history of neurological disease, post-traumatic stress disorder or other psychiatric disorder, or who have a history of physical or sexual abuse may not participate. Candidates will be screened with a written questionnaire and a medical history, including psychiatric and neurological information.
Participants will perform tasks involving emotions while undergoing MRI scanning. For this procedure, the subject lies on a table in a narrow metal cylinder (the scanner) containing a magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. The subject is asked to lie still for up to 10 minutes at a time. During the scan, the subject performs simple tasks involving the viewing of pictures on a screen. Other tasks involve viewing pictures and responding to them by pressing buttons. Some pictures are violent or pornographic, while others are pleasant to view. Of a total of 162 pictures, 30 percent are categorized as graphic and possibly disturbing.
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 experimental neuropsychological tasks during functional MRI on healthy adult volunteers, we will investigate hypotheses regarding the role of the ventromedial prefrontal cortex in social cognition and emotional processing as opposed to the dorsolateral prefrontal cortex, involved in nonsocial-events (planning, problem solving, economic exchange and reasoning). 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. Another goal of our study is to test different fMRI sequences to determine which one gives us the best quality of signal in the amygdala and orbitofrontal cortex (affected by signal drop-out due to magnetic susceptibility artifacts). 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) contributing to optimization of functional imaging of the amygdala and orbitofrontal cortex at high field strength (3 Tesla). We will also use the data obtained in these studies to constrain theories of frontal lobe function and to provide evidence for the role of specific frontal cortex sectors in specific cognitive functions.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The study population will consist of young healthy volunteers.
- Age range: 18 to 40
- Right-handedness (some left-handed subjects may be recruited for preliminary behavioral studies)
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.
- Individuals with a current or past history of post-traumatic stress disorder or other psychiatric disorder or individuals with a history of physical or sexual abuse will be excluded as they may be disturbed by viewing graphic pictures.
- Subjects with contraindications to exposure to high magnetic field.
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 8905689Bodner M, Kroger J, Fuster JM. Auditory memory cells in dorsolateral prefrontal cortex. Neuroreport. 1996 Aug 12;7(12):1905-8. doi: 10.1097/00001756-199608120-00006.
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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 3 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 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 NCT00061204, 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.