HealthyNCT00458432
Functional Neuroanatomy of Emotion Perception, Recognition, Learning, and Memory
An observational study of Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study uses magnetic resonance imaging (MRI) to explore the areas of the brain involved in different types of mental processes, in particular, the brain regions involved in perception, recognition, learning, and memory. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2007to 31 Aug 2009
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal right-handed volunteers with at least a high school education, age 20 to 40 years, will be recruited to participate in this study.
Who cannot join
- Subjects will be excluded if they have evidence of or a history of learning disability, psychiatric condition, head trauma, seizures or other neurological condition, alcoholism or substance abuse, hypertension, or cardiovascular disease. We will also exclude subjects with vision and/or hearing problems severe enough to interfere with testing. Lab work will be limited to a urine pregnancy test for females. Females with a positive pregnancy test will be excluded from neuroimaging studies. All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Those whose history is suggestive of such a problem will be excluded. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded because of possible risks during MRI scanning.
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
This study uses magnetic resonance imaging (MRI) to explore the areas of the brain involved in different types of mental processes, in particular, the brain regions involved in perception, recognition, learning, and memory. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. In this study it is also used to measure blood flow in different regions of the brain while the subject is presented auditory or visual stimuli. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. Subjects are in the scanner no more than 2 hours.
Healthy, right-handed normal volunteers between 20 and 40 years of age who have at least a high school education may be eligible for this study.
Read more
While undergoing MRI, participants are presented visual stimuli (pictures or geometric shapes on a projection screen) or auditory stimuli (tones played through a set of headphones). Unpleasant stimuli such as loud noise, electric shocks, heat, or tactile stimuli are administered occasionally. The intensity of these stimuli is similar to those experienced in practice sessions before the scanning. Participants receive between 30 and 60 visual or auditory stimuli during the scanning session, and each stimulus lasts about 1 second. In some studies participants are asked to move a joystick that controls a rating bar presented on a projection screen to indicate when they expect to receive these stimuli and how sure they are that they will occur. Heart rate, respiration rate, and sweat gland activity are monitored during the MRI sessions, using electrodes placed on the fingers to measure heart rate and sweat gland activity and a sensor strapped around the chest to measure respiration. Subjects are in the scanner no more than 2 hours.
Following the experiment, subjects may be asked questions about their experiences during the study.
Read the detailed description
The long-term goals of this study are to understand the neural substrates of aversive Pavlovian conditioning in human subjects. The general approach is to use whole brain functional magnetic resonance imaging (fMRI) to describe brain regions and circuits that contribute to the acquisition and performance of this form of learning. The specific aims of this proposal are:
- To identify brain regions that respond to aversive stimuli.
- To identify brain regions primarily responsible for the expression of cognitive and autonomic responses versus those involved in stimulus processing and memory encoding.
- To relate patterns of activity within selected brain areas to implicit versus explicit memory performance.
- To compare the parallel development of implicit and explicit knowledge about stimulus relationships during Pavlovian delay and trace fear conditioning.
- To test specific predictions regarding the nature of learning-related activity in the amygdala, hippocampus, anterior cingulate, and prefrontal cortex as they develop during conditioning and to integrate these findings into a more general theoretical understanding of memory phenomena in humans.
- Conditions
- Healthy
- Keywords
- fMRI, Pavlovian Conditioning, Functional Activity, Brain, Fear, 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 posted10 Apr 2007 (estimated)
- Study start5 Apr 2007
- Primary completion31 Aug 2009
- Study completion31 Aug 2009
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 Mental Health (NIMH)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
- Time perspective
- Prospective
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458432
- Sponsor's protocol ID
- 070127
- Other IDs
- 07-M-0127
- Status last verified
- 8 Jun 2009
- First submitted
- 7 Apr 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Baumgartner U, Magerl W, Klein T, Hopf HC, Treede RD. Neurogenic hyperalgesia versus painful hypoalgesia: two distinct mechanisms of neuropathic pain. Pain. 2002 Mar;96(1-2):141-51. doi: 10.1016/s0304-3959(01)00438-9.
PubMed 11932070Bechara A, Tranel D, Damasio H, Adolphs R, Rockland C, Damasio AR. Double dissociation of conditioning and declarative knowledge relative to the amygdala and hippocampus in humans. Science. 1995 Aug 25;269(5227):1115-8. doi: 10.1126/science.7652558.
PubMed 7652558Andrew D, Greenspan JD. Peripheral coding of tonic mechanical cutaneous pain: comparison of nociceptor activity in rat and human psychophysics. J Neurophysiol. 1999 Nov;82(5):2641-8. doi: 10.1152/jn.1999.82.5.2641.
PubMed 10561433
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
- Functional Neuroanatomy of Emotion Perception, Recognition, Learning, and Memory
- ClinicalTrials.gov ID
- NCT00458432
- Acronym / sponsor ID
- 070127
- Conditions
- Healthy
- Keywords
- fMRI, Pavlovian Conditioning, Functional Activity, Brain, Fear, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Apr 2007
- Primary completion
- 31 Aug 2009 (actual)
- Study completion
- 31 Aug 2009 (actual)
- First posted
- 10 Apr 2007 (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 uses magnetic resonance imaging (MRI) to explore the areas of the brain involved in different types of mental processes, in particular, the brain regions involved in perception, recognition, learning, and memory. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. In this study it is also used to measure blood flow in different regions of the brain while the subject is presented auditory or visual stimuli. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. Subjects are in the scanner no more than 2 hours.
Healthy, right-handed normal volunteers between 20 and 40 years of age who have at least a high school education may be eligible for this study.
While undergoing MRI, participants are presented visual stimuli (pictures or geometric shapes on a projection screen) or auditory stimuli (tones played through a set of headphones). Unpleasant stimuli such as loud noise, electric shocks, heat, or tactile stimuli are administered occasionally. The intensity of these stimuli is similar to those experienced in practice sessions before the scanning. Participants receive between 30 and 60 visual or auditory stimuli during the scanning session, and each stimulus lasts about 1 second. In some studies participants are asked to move a joystick that controls a rating bar presented on a projection screen to indicate when they expect to receive these stimuli and how sure they are that they will occur. Heart rate, respiration rate, and sweat gland activity are monitored during the MRI sessions, using electrodes placed on the fingers to measure heart rate and sweat gland activity and a sensor strapped around the chest to measure respiration. Subjects are in the scanner no more than 2 hours.
Following the experiment, subjects may be asked questions about their experiences during the study.
Detailed description
The long-term goals of this study are to understand the neural substrates of aversive Pavlovian conditioning in human subjects. The general approach is to use whole brain functional magnetic resonance imaging (fMRI) to describe brain regions and circuits that contribute to the acquisition and performance of this form of learning. The specific aims of this proposal are:
- To identify brain regions that respond to aversive stimuli.
- To identify brain regions primarily responsible for the expression of cognitive and autonomic responses versus those involved in stimulus processing and memory encoding.
- To relate patterns of activity within selected brain areas to implicit versus explicit memory performance.
- To compare the parallel development of implicit and explicit knowledge about stimulus relationships during Pavlovian delay and trace fear conditioning.
- To test specific predictions regarding the nature of learning-related activity in the amygdala, hippocampus, anterior cingulate, and prefrontal cortex as they develop during conditioning and to integrate these findings into a more general theoretical understanding of memory phenomena in humans.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal right-handed volunteers with at least a high school education, age 20 to 40 years, will be recruited to participate in this study.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they have evidence of or a history of learning disability, psychiatric condition, head trauma, seizures or other neurological condition, alcoholism or substance abuse, hypertension, or cardiovascular disease. We will also exclude subjects with vision and/or hearing problems severe enough to interfere with testing. Lab work will be limited to a urine pregnancy test for females. Females with a positive pregnancy test will be excluded from neuroimaging studies. All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Those whose history is suggestive of such a problem will be excluded. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded because of possible risks during MRI scanning.
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 11932070Baumgartner U, Magerl W, Klein T, Hopf HC, Treede RD. Neurogenic hyperalgesia versus painful hypoalgesia: two distinct mechanisms of neuropathic pain. Pain. 2002 Mar;96(1-2):141-51. doi: 10.1016/s0304-3959(01)00438-9.
- Background: PubMed 7652558Bechara A, Tranel D, Damasio H, Adolphs R, Rockland C, Damasio AR. Double dissociation of conditioning and declarative knowledge relative to the amygdala and hippocampus in humans. Science. 1995 Aug 25;269(5227):1115-8. doi: 10.1126/science.7652558.
- Background: PubMed 10561433Andrew D, Greenspan JD. Peripheral coding of tonic mechanical cutaneous pain: comparison of nociceptor activity in rat and human psychophysics. J Neurophysiol. 1999 Nov;82(5):2641-8. doi: 10.1152/jn.1999.82.5.2641.
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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 Mental Health (NIMH) 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 1 inclusion and 1 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 NCT00458432, 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; AzTrials last refreshed its copy on 1 Nov 2026.