An fMRI Study of Attention and Effort After Concussion

• ClinicalTrials.gov Identifier: NCT00653029
• Recruitment Status: Terminated
• First Posted: April 4, 2008
• Last Update Posted: May 3, 2016
• Sponsor: State University of New York - Upstate Medical University
• Information provided by (Responsible Party): Brian Rieger, State University of New York - Upstate Medical University

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
Post Concussive Syndrome

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: October 2006
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• 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

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
• Other Study ID Numbers: 5406
• 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:

Post-Concussion Syndrome; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating