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Clinical Trials/NCT00653029
NCT00653029
Terminated
Not Applicable

An fMRI Study of Selective Attention, Working Memory, and Effort After Mild Traumatic Brain Injury

State University of New York - Upstate Medical University1 site in 1 country12 target enrollmentOctober 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Concussive Syndrome
Sponsor
State University of New York - Upstate Medical University
Enrollment
12
Locations
1
Primary Endpoint
BOLD Response
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
November 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University
Responsible Party
Principal Investigator
Principal Investigator

Brian Rieger

Chief Psychologist PM&R

State University of New York - Upstate Medical University

Eligibility 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

Outcomes

Primary Outcomes

BOLD Response

Time Frame: Patients will undergo fMRI at least one month after injury

Blood Oxygen Level Dependent Response protocol on fMRI

Study Sites (1)

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