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
  Purpose

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.


Condition
Post Concussive Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: An fMRI Study of Selective Attention, Working Memory, and Effort After Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Biospecimen Retention:   None Retained

No biospecimens


Estimated Enrollment: 20
Study Start Date: October 2006
Estimated Study Completion Date: December 2009
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653029

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13201
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Dominic A Carone, PhD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Dominic A. Carone, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00653029     History of Changes
Other Study ID Numbers: 5406
Study First Received: April 1, 2008
Last Updated: December 1, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Post concussion syndrome
Mild traumatic brain injury
Effort
fmri

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on April 17, 2014