Trial record 18 of 27 for:    Open Studies | "Brain Concussion"

Measure of Cerebrovascular Dysfunction After TBI With fNIRS

This study is currently recruiting participants.
Verified February 2013 by Uniformed Services University of the Health Sciences
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT01789164
First received: February 7, 2013
Last updated: February 8, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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.


Secondary Outcome Measures:
  • Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls [ Time Frame: Two years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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)
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD Uniformed Services University of the Health Sciences
  More Information

No publications provided

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
Study First Received: February 7, 2013
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:
TBI
fNIRS
hypercapnea
Cerebrovascular reactivity

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

ClinicalTrials.gov processed this record on April 17, 2014