Measure of Cerebrovascular Dysfunction After TBI With fNIRS
|ClinicalTrials.gov Identifier: NCT01789164|
Recruitment Status : Unknown
Verified December 2015 by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences.
Recruitment status was: Recruiting
First Posted : February 11, 2013
Last Update Posted : January 1, 2016
|Condition or disease|
|Traumatic Brain Injury Post-concussion Syndrome|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Measure of Cerebrovascular Dysfunction After Truamatic Brain Injury With Functional Near Infrared Spectroscopy|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||February 2016|
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
- Reproducibility of CVR measurements with fNIRS during intersession and intra-session testing [ Time Frame: Two years ]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 ]
- The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms [ Time Frame: Two years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789164
|United States, Maryland|
|Center for Neuroscience and Regenerative Medicine (CNRM)||Recruiting|
|Rockville, Maryland, United States, 20851|
|Contact: Kimbra Kenney, MD 301-295-6420 email@example.com|
|Principal Investigator: Ramon Diaz-Arrastia, MD, PhD|
|Principal Investigator:||Ramon Diaz-Arrastia, MD, PhD||Uniformed Services University of the Health Sciences|