This trial is active, not recruiting.

Condition post concussive syndrome
Sponsor State University of New York - Upstate Medical University
Start date October 2006
End date December 2009
Trial size 20 participants
Trial identifier NCT00653029, 5406


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title An fMRI Study of Selective Attention, Working Memory, and Effort After Mild Traumatic Brain Injury
Principal investigator Dominic A Carone, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by State University of New York - Upstate Medical University.