An fMRI Study of Attention and Effort After Concussion

NCT00653029 | Terminated

• 1 other identifier: 5406
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Post concussion syndrome; Mild traumatic brain injury; Effort; fmri

Outcome Measures

Primary Outcomes (1)

• BOLD Response

  Blood Oxygen Level Dependent Response protocol on fMRI

  Patients will undergo fMRI at least one month after injury

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13201, United States

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Dominic A Carone, PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Psychologist PM&R

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: October 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

US (1)