An fMRI Study of Attention and Effort After Concussion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by State University of New York - Upstate Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00653029
First received: April 1, 2008
Last updated: December 1, 2008
Last verified: December 2008

April 1, 2008
December 1, 2008
October 2006
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Complete list of historical versions of study NCT00653029 on ClinicalTrials.gov Archive Site
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An fMRI Study of Attention and Effort After Concussion
An fMRI Study of Selective Attention, Working Memory, and Effort After Mild Traumatic Brain Injury

Approximately 1.1 million people a year suffer a mild traumatic brain injury (MTBI), or concussion, in the United States. Although most MTBI patients fully recover, as many as 28% have physical, cognitive, and/or emotional symptoms up to 6 months post-injury. When symptoms persist past three months, it is known as post-concussion syndrome (PCS). The cause of PCS is unknown, as structural neuroimaging and neuropsychological (NP) testing results are often normal. However, recent functional magnetic resonance imaging (fMRI) research in concussed adults showed differences in brain activity compared to controls on working memory tasks, despite normal structural MRI and neuropsychological findings. We propose improving this research by assessing brain activation patterns during simple versus complex attention and working memory tasks in 10 concussed adults via fMRI. This will be the first study to examine brain activation patterns associated with the degree of effort applied to testing, a factor known to confound interpretation of NP test performance. Validated computerized measures of selective attention (Modified Stroop Interference Task), working memory (n-back), and effort (Green's Medical Symptom Validity Test; MSVT) will be used. Ten paid controls will be used for comparative purposes. We hypothesize that concussed patients will show less brain activation than controls on complex versus simple working memory tasks and that activation patterns in concussed patients will generally be lower in those with suboptimal effort. We will also characterize self-reported emotional and physical symptoms in the PCS patients, which has not been done in prior fMRI research with this population.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   None Retained
Description:

No biospecimens

Probability Sample

Community sample

Post Concussive Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2009
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Inclusion Criteria:

  • Mild TBI (based on criteria of the American Congress of Rehabilitation Medicine)
  • Aged 18 to 60
  • History of non-penetrating head injury
  • Obtaining medical assistance (e.g., personal physician, Emergency Room) within 24 hours post-injury

Exclusion Criteria:

  • No prior history of prior post-concussion syndrome (i.e, uncomplicated mild TBI)
  • Moderate to severe TBI
  • Substance dependence
  • Learning disorder
  • Attention-deficit disorder
  • Mental retardation
  • Severe psychiatric disorder requiring hospitalization
  • Previous central nervous system disease
  • Absence of neurosurgery
  • No evidence of alcohol/drug use related to the injury
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00653029
5406
No
Dominic A. Carone, SUNY Upstate Medical University
State University of New York - Upstate Medical University
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Principal Investigator: Dominic A Carone, PhD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP