An fMRI Study of Attention and Effort After Concussion

NCT ID: NCT00653029

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-11-30

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.

Conditions

Post Concussive Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Brian Rieger

Chief Psychologist PM&R

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominic A Carone, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

5406

Identifier Type: -

Identifier Source: org_study_id