Measure of Cerebrovascular Dysfunction After TBI With fNIRS

NCT01789164 | Completed

• 1 other identifier: G189AP-S2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Post-concussion Syndrome

Keywords

TBI; fNIRS; hypercapnea; Cerebrovascular reactivity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls

  Two years

Other Outcomes (1)

• The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms

  Two years

Study Arms (2)

Healthy group

Healthy group with no history of TBI or concussion. Gender matched non-TBI volunteers

TBI group

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• ALL participants (TBI and non-TBI) subjects Males and females, ages 18 to 60 years, inclusive Able to read, write, speak and understand English
• A history of TBI
• Persistent post-concussive symptoms, according to the DSM-IV Research
• Criteria for Post-Concussional Disorder, including:
• Evidence from neuropsychological testing of difficulty in attention or memory. (refers to neuropsychological testing done as a part of the patient's hospital or rehabilitation care not as a part of screening for this study)
• Three or more of the following symptoms, which started shortly after the trauma and persist for at least three months:
• Fatigability
• Disordered sleep
• Headache
• Vertigo or dizziness
• Irritability or aggression
• Anxiety, depression, or affective instability
• Changes in personality (e.g. social or sexual inappropriateness)
• Apathy or lack of spontaneity
• Symptoms in criteria (a) and (b) must have their onset after trauma, or there was a significant worsening of pre-existing symptoms after trauma.

You may not qualify if:

• History or evidence of pre-existing neurological or psychiatric disorder not related to TBI, such as:
• Multiple sclerosis, pre- or co-existing
• Stroke (other than stroke at the time of TBI)
• Pre-existing developmental disorder
• Pre-existing epilepsy
• Pre-existing major depressive disorder
• Pre-existing schizophrenia
• Known allergy to latex (used in the NIRS apparatus band applied to the forehead)

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

Center for Neuroscience and Regenerative Medicine (CNRM)

Rockville, Maryland, 20851, United States

Location

Related Publications (3)

• 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.

  PMID: 26048614 RESULT

• 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.

  PMID: 31790877 RESULT

• 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.

  PMID: 34873185 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Ramon Diaz-Arrastia, MD, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)