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Measure of Cerebrovascular Dysfunction After TBI With fNIRS

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789164
First Posted: February 11, 2013
Last Update Posted: January 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Center for Neuroscience and Regenerative Medicine (CNRM)
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
  Purpose
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.

Condition
Traumatic Brain Injury Post-concussion Syndrome

Study Type: Observational
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

Further study details as provided by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls [ Time Frame: Two years ]

Other Outcome Measures:
  • The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms [ Time Frame: Two years ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  1. ALL participants (TBI and non-TBI) subjects Males and females, ages 18 to 60 years, inclusive Able to read, write, speak and understand English
  2. A history of TBI
  3. Persistent post-concussive symptoms, according to the DSM-IV Research
  4. 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.

Exclusion Criteria:

  1. 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
  2. Known allergy to latex (used in the NIRS apparatus band applied to the forehead)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789164


Locations
United States, Maryland
Center for Neuroscience and Regenerative Medicine (CNRM) Recruiting
Rockville, Maryland, United States, 20851
Contact: Kimbra Kenney, MD    301-295-6420    kimbra.kenney@usuhs.edu   
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD         
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
Investigators
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD Uniformed Services University of the Health Sciences
  More Information

Responsible Party: Ramon Diaz-Arrastia, Director of Clinical Research, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01789164     History of Changes
Other Study ID Numbers: G189AP-S2
First Submitted: February 7, 2013
First Posted: February 11, 2013
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences:
TBI
fNIRS
hypercapnea
Cerebrovascular reactivity

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating