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An fMRI Study of Attention and Effort After Concussion

Sponsor
State University of New York - Upstate Medical University (Other)
Overall Status
Terminated
CT.gov ID
NCT00653029
Collaborator
(none)
12
Enrollment
1
Location
73
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    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
    Study Start Date :
    Oct 1, 2006
    Actual Primary Completion Date :
    Nov 1, 2012
    Actual Study Completion Date :
    Nov 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. BOLD Response [Patients will undergo fMRI at least one month after injury]

      Blood Oxygen Level Dependent Response protocol on fMRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Rieger, Chief Psychologist PM&R, State University of New York - Upstate Medical University
    ClinicalTrials.gov Identifier:
    NCT00653029
    Other Study ID Numbers:
    • 5406
    First Posted:
    Apr 4, 2008
    Last Update Posted:
    May 3, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Brian Rieger, Chief Psychologist PM&R, State University of New York - Upstate Medical University
    Post concussion syndrome
    Mild traumatic brain injury
    Effort
    fmri
    Additional relevant MeSH terms:
    Post-Concussion Syndrome

    Study Results

    No Results Posted as of May 3, 2016