Healthy Volunteers Clinical Trial
Official title:
Functional Neuro-Imaging of Strategy Use During Human Behavior
| Verified date | May 26, 2010 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | May 26, 2010 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
- INCLUSION CRITERIA: - 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. EXCLUSION CRITERIA: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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. — View Citation
Bunge SA, Wright SB. Neurodevelopmental changes in working memory and cognitive control. Curr Opin Neurobiol. 2007 Apr;17(2):243-50. Epub 2007 Feb 23. Review. — View Citation
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. Review. — View Citation
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