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An fMRI Study of Attention and Effort After Concussion

This study has been terminated.
(Difficulties with recruitment and MRI scanner became unavailable.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653029
First Posted: April 4, 2008
Last Update Posted: May 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Rieger, State University of New York - Upstate Medical University
  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 Brian Rieger, State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • BOLD Response [ Time Frame: Patients will undergo fMRI at least one month after injury ]
    Blood Oxygen Level Dependent Response protocol on fMRI


Biospecimen Retention:   None Retained
No biospecimens

Enrollment: 12
Study Start Date: October 2006
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Brian Rieger, Chief Psychologist PM&R, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00653029     History of Changes
Other Study ID Numbers: 5406
First Submitted: April 1, 2008
First Posted: April 4, 2008
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Brian Rieger, 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, Traumatic
Post-Concussion Syndrome
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating