NCT00060853

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2003

Completed
Same day until next milestone

First Posted

Study publicly available on registry

May 14, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2005

First QC Date

May 14, 2003

Last Update Submit

March 3, 2008

Conditions

Healthy

Keywords

AmygdalaOrbitofrontal CortexEmotionCognitionTheory of MindHealthy VolunteerHV

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 1948051BACKGROUND

  • Belliveau 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.

    PMID: 2355835BACKGROUND

  • Bergeron 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.

    PMID: 9184663BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 14, 2003

First Posted

May 14, 2003

Study Start

May 1, 2003

Study Completion

May 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-05

Locations

US(1)