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NCT00653029 · ClinicalTrials.gov registry record
An fMRI Study of Attention and Effort After Concussion
A clinical trial, sponsored by State University of New York - Upstate Medical University.
- Terminated
- Registry status
- 12
- Enrollment target
NCT00653029: Clinical Trial study, sponsored by State University of New York - Upstate Medical University.
NCT00653029 is a clinical trial that was terminated before completion, run by State University of New York - Upstate Medical University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00653029 was terminated before completion, sponsored by State University of New York - Upstate Medical University.
- TERMINATED
- Registry status
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Blood Oxygen Level Dependent Response protocol on fMRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-10 |
| Est. Completion | 2012-11 |
Why NCT00653029 stopped before completion
NCT00653029 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00653029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00653029 about?
NCT00653029 is a clinical study titled "An fMRI Study of Attention and Effort After Concussion". 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,...
What is the current status of trial NCT00653029?
This trial is currently terminated. The enrollment target is 12 participants. The study started on 2006-10. Estimated completion is 2012-11.
Who is sponsoring clinical trial NCT00653029?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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