NCT01789164|Completed
Loading search results
Sponsor study identifier
observational
100
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 7, 2013
Actual (reported)February 11, 2013
Actual (reported)December 2015
Actual (reported)December 2015
Actual (reported)Reproducibility of CVR measurements with fNIRS during intersession and intra-session testing
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.
Two years
Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls
Two years
The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms
Two years
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
Males and females (military health care beneficiaries and non military health care beneficiaries) 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.
Center for Neuroscience and Regenerative Medicine (CNRM)
Rockville, Maryland, 20851, United States
Kenney K, Amyot F, Haber M, Pronger A, Bogoslovsky T, Moore C, Diaz-Arrastia R. Cerebral Vascular Injury in Traumatic Brain Injury. Exp Neurol. 2016 Jan;275 Pt 3:353-366. doi: 10.1016/j.expneurol.2015.05.019. Epub 2015 Jun 3.
Amyot F, Kenney K, Spessert E, Moore C, Haber M, Silverman E, Gandjbakhche A, Diaz-Arrastia R. Assessment of cerebrovascular dysfunction after traumatic brain injury with fMRI and fNIRS. Neuroimage Clin. 2020;25:102086. doi: 10.1016/j.nicl.2019.102086. Epub 2019 Nov 11.
Ramon Diaz-Arrastia, MD, PhD
Uniformed Services University of the Health Sciences
100 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2013
First Posted
February 11, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Reddy P, Izzetoglu M, Shewokis PA, Sangobowale M, Diaz-Arrastia R, Izzetoglu K. Evaluation of fNIRS signal components elicited by cognitive and hypercapnic stimuli. Sci Rep. 2021 Dec 6;11(1):23457. doi: 10.1038/s41598-021-02076-7.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
January 17, 2019
Record last verified: 2019-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: