NCT00728741

Brief Summary

This study will locate areas in the brain that help people devise action plans to carry out complex tasks requiring use of strategy. The ability to plan strategically is impaired in patients who have had a stroke affecting the front parts of the brain. This study will use functional magnetic resonance imaging (fMRI) to examine the activity of different areas of the brain during the formulation and execution of plans. Right-handed healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH Clinical Center four to five times to complete the following procedures: Visit 1 - Screening

  • Medical history
  • Physical and neurological examinations Visit 2 - MRI brain scan (if one has not been done within the past year) MRI - This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning. Visits 3 to 5 - Task training sessions and two fMRI scans Functional MRI involves taking MRI scans while the subject performs a task in order to learn about changes in brain regions that are involved in the performance of the task. Subjects are trained in two tasks (see below) and then perform the tasks while in the MRI scanner.
  • Task 1: The subject presses computer keys in response to the direction of arrows shown on the computer screen. The keys are pressed according to a given set of rules the subject is taught.
  • Task 2: This task is similar to task 1, but the subject is also asked to remember certain previous actions and responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2010

Completed
Last Updated

July 2, 2017

Status Verified

May 26, 2010

First QC Date

August 5, 2008

Last Update Submit

June 30, 2017

Conditions

Keywords

Neural NetworksCortical ActivationStrategyfMRIHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects from ages 18 to 60
  • Subjects must be right-hand dominant as defined by the Edinburgh Handedness inventory: (R. C. Oldfield, 1971) -Right lateralized handedness quotient of greater than 0.75 will be considered R handed)
  • Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the FMRI scanning.

You may not qualify if:

  • Subjects with clinically significant abnormal findings on neurological exam in any of the following neurological domains: cognitive, cranial nerve, motor, sensory, cerebellar functions.
  • Subjects who are pregnant (as determined by positive urine pregnancy test)
  • Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
  • Subjects with metallic dental fillings which are likely to cause MRI artifacts
  • Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
  • Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 120 minutes
  • Subjects without the capacity to give informed consent
  • Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Blakemore SJ, Goodbody SJ, Wolpert DM. Predicting the consequences of our own actions: the role of sensorimotor context estimation. J Neurosci. 1998 Sep 15;18(18):7511-8. doi: 10.1523/JNEUROSCI.18-18-07511.1998.

    PMID: 9736669BACKGROUND
  • Bunge SA. How we use rules to select actions: a review of evidence from cognitive neuroscience. Cogn Affect Behav Neurosci. 2004 Dec;4(4):564-79. doi: 10.3758/cabn.4.4.564.

    PMID: 15849898BACKGROUND
  • Bunge SA, Wright SB. Neurodevelopmental changes in working memory and cognitive control. Curr Opin Neurobiol. 2007 Apr;17(2):243-50. doi: 10.1016/j.conb.2007.02.005. Epub 2007 Feb 23.

    PMID: 17321127BACKGROUND

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 6, 2008

Study Start

August 1, 2008

Study Completion

May 26, 2010

Last Updated

July 2, 2017

Record last verified: 2010-05-26

Locations