An fMRI Study of Attention and Effort After Concussion

Post Concussive Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00653029
• Other study ID #: 5406
• Status: Terminated
• Phase: N/A
• First received: April 1, 2008
• Last updated: May 1, 2016
• Start date: October 2006
• Est. completion date: November 2012

Study information

• Verified date: May 2016
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Concussion
• Post Concussive Syndrome
• Post-Concussion Syndrome

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD Response	Blood Oxygen Level Dependent Response protocol on fMRI	Patients will undergo fMRI at least one month after injury	No