- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653029
An fMRI Study of Attention and Effort After Concussion
May 1, 2016 updated by: Brian Rieger, State University of New York - Upstate Medical University
An fMRI Study of Selective Attention, Working Memory, and Effort After Mild Traumatic Brain Injury
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Syracuse, New York, United States, 13201
- SUNY Upstate Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Community sample
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD Response
Time Frame: Patients will undergo fMRI at least one month after injury
|
Blood Oxygen Level Dependent Response protocol on fMRI
|
Patients will undergo fMRI at least one month after injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dominic A Carone, PhD, State University of New York - Upstate Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 3, 2008
First Posted (Estimate)
April 4, 2008
Study Record Updates
Last Update Posted (Estimate)
May 3, 2016
Last Update Submitted That Met QC Criteria
May 1, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5406 (OPD)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Concussive Syndrome
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Vancouver General HospitalUnknownPost Concussive Syndrome | Post Concussive HeadacheCanada
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Essentia HealthUniversity of North Dakota; Dakota Medical Foundation; The Swanson Foundation; State...Active, not recruitingConcussion Post Syndrome | Persistent Post-concussive SyndromeUnited States
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Lakehead UniversityNorthern Ontario School of MedicineWithdrawnPersistent Post-Concussive SyndromeCanada
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Spaulding Rehabilitation HospitalRio Grande NeurosciencesWithdrawnConcussion | Post Concussive Syndrome
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Brain Trauma FoundationUnited States Department of DefenseCompleted
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Norwegian University of Science and TechnologyCompletedBrain Injuries | Post-Concussive Symptom | Post-Concussive SyndromeNorway
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University of AarhusFonden til Lægevidenskabens Fremme; Sygekassernes Helsefond; Region MidtJylland... and other collaboratorsCompletedPost Concussive Symptoms
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Children's Hospital of Eastern OntarioThe Hospital for Sick Children; Western University, Canada; Holland Bloorview... and other collaboratorsCompletedPost-Concussive Symptoms | ConcussionsCanada
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Uniformed Services University of the Health SciencesNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes... and other collaboratorsCompletedTraumatic Brain Injury | Post-concussive SyndromeUnited States
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Medical College of WisconsinCompletedMild Traumatic Brain Injury | Concussion | Post-concussive SyndromeUnited States