Measure of Cerebrovascular Dysfunction After TBI With fNIRS
The goal of this project is to determine if it is possible to assess Cerebrovascular Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a method would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in standard clinical practice.
Traumatic Brain Injury
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Measure of Cerebrovascular Dysfunction After Truamatic Brain Injury With Functional Near Infrared Spectroscopy|
- Reproducibility of CVR measurements with fNIRS during intersession and intra-session testing [ Time Frame: Two years ] [ Designated as safety issue: No ]Establish reproducibility of CVR measurements with fNIRS during intersession and intra-session testing. Additionally, we will examine two methods of producing hypercapnia, breath holding and the Douglas bag methods to establish whether the two methods give similar NIRS results.
- Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls [ Time Frame: Two years ] [ Designated as safety issue: No ]
- The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms [ Time Frame: Two years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Healthy group with no history of TBI or concussion. Gender matched non-TBI volunteers
Males and females between 18 and 60 years who have a diagnosis of TBI and are symptomatic with DSM-IV Research Criteria for Post-Concussional Disorder (see below), gender matched non-TBI volunteers
The prospective study design will consist of two study groups; the experimental group and the control group. In the Experimental Group (Group 1) we will enroll adult participants with TBI with persistent post-concussion symptoms or abnormalities on neuropsychological testing. In Group 2 we will enroll adult participants to serve as age and gender-matched healthy controls. Our goal is to recruit 100 subjects total in two groups of age and gender matched subjects, as follows: TBI (n = 50) and non-TBI (n = 50).
Participants in both groups will undergo NIRS testing with hypercapnia challenge, to measure the increase in hemodynamic flow signal during hypercapnia challenge via 2 methods, the breath holding and the Douglas bag methods. We will test intersessional validity of the NIRS-hypercapnia challenge in the first 20 (10 TBI and 10 non-TBI) subjects who are willing to return for a second visit of repeat testing.
The NIRS system is composed of 4 light sources and 10 detectors with a 16 point configuration system applied on the forehead of the subject. In our experiment, light intensity collected at each detector will be transformed into a signal related to the local concentrations of oxy- and de-oxyhemoglobin during the challenge. Each experiment will give a set of subject data, consisting of the peak amplitude and time-to-peak of the hemodynamic signals measured.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789164
|United States, Maryland|
|Center for Neuroscience and Regenerative Medicine (CNRM)||Recruiting|
|Rockville, Maryland, United States, 20851|
|Contact: Kimbra Kenney, MD 301-295-6420 firstname.lastname@example.org|
|Principal Investigator: Ramon Diaz-Arrastia, MD, PhD|
|Principal Investigator:||Ramon Diaz-Arrastia, MD, PhD||Uniformed Services University of the Health Sciences|