fMRI and NIRS Imaging for Traumatic Brain Injury
|First Received Date ICMJE||August 16, 2012|
|Last Updated Date||January 20, 2017|
|Start Date ICMJE||July 25, 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01668758 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||The secondary outcome of the two parametric paradigms will investigate if the degree of disruption correlates with measures of the severity of injury (GC scale). Finally, we will compare individual measurement form TBI patient with the health...|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||fMRI and NIRS Imaging for Traumatic Brain Injury|
|Official Title ICMJE||Detection of Hemodynamic Changes in Traumatic Brain Injuries Population With Functional Near Infrared Spectroscopy|
- The amount of blood flowing in brain areas goes up when those areas are being used for activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI. Researchers want to compare fMRI and NIRS to see whether they give similar results. These studies will be used to look at people who have had a traumatic brain injury.
- To test how well NIRS measure changes in blood flow in the brain after a traumatic brain injury.
The goal of this study is to be able to assess frontal lobe function in a rapid, objective, and standardized way, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in mild traumatic brain injury, where objective measures are needed, and would greatly expand the capacity to make such assessments in standard clinical practice.
Our goal is to recruit 100 subjects total in two groups of age, gender, and education matched subjects, as follows: TBI (n = 50) and non-TBI (n = 50).
The subject will be asked to perform 2 computer-based cognitive tests while the fNIRS device is in place. The fNIRS sensor pads will record changes in blood oxy/deoxy hemoglobin concentrations in the underlying cortex. Data will be stored for post processing analysis.
The main outcome measures will be: 1) a correlation of the fNIRS results between the TBI and non-TBI groups; 2) a correlation of the fNIRS results with the severity of the TBI within the TBI group. Finally, we plan to compare individual measurement from TBI patients with the healthy group.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Estimated Completion Date||July 1, 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
- Age 18 to 60, inclusive.
Traumatic brain injuries population
|Ages||18 Years to 60 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT01668758|
|Other Study ID Numbers ICMJE||120165, 12-CH-0165|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 1, 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP