<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668758</url>
  </required_header>
  <id_info>
    <org_study_id>120165</org_study_id>
    <secondary_id>12-CH-0165</secondary_id>
    <nct_id>NCT01668758</nct_id>
  </id_info>
  <brief_title>fMRI and NIRS Imaging for Traumatic Brain Injury</brief_title>
  <official_title>Detection of Hemodynamic Changes in Traumatic Brain Injuries Population With Functional Near Infrared Spectroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - The amount of blood flowing in brain areas goes up when those areas are being used for&#xD;
      activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a&#xD;
      common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also&#xD;
      be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI.&#xD;
      Researchers want to compare fMRI and NIRS to see whether they give similar results. These&#xD;
      studies will be used to look at people who have had a traumatic brain injury.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To test how well NIRS measure changes in blood flow in the brain after a traumatic brain&#xD;
      injury.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Individuals between 18 and 60 years of age who have had a traumatic brain injury.&#xD;
&#xD;
        -  Healthy volunteers at least 18 years of age.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with a physical exam and medical history. Researchers may&#xD;
           ask to see brain images during from previous MRI scans.&#xD;
&#xD;
        -  Participants will have a NIRS scan of the brain. They will be asked to do certain tasks&#xD;
           while inside the scanner. These tasks will involve responding to images that appear on a&#xD;
           screen.&#xD;
&#xD;
        -  Treatment will not be provided as part of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to be able to assess frontal lobe function in a rapid, objective,&#xD;
      and standardized way, without the need for expertise in cognitive test administration. Such&#xD;
      methods would be particularly helpful in mild traumatic brain injury, where objective&#xD;
      measures are needed, and would greatly expand the capacity to make such assessments in&#xD;
      standard clinical practice.&#xD;
&#xD;
      Our goal is to recruit 100 subjects total in two groups of age, gender, and education matched&#xD;
      subjects, as follows: TBI (n = 50) and non-TBI (n = 50).&#xD;
&#xD;
      The subject will be asked to perform 2 computer-based cognitive tests while the fNIRS device&#xD;
      is in place. The fNIRS sensor pads will record changes in blood oxy/deoxy hemoglobin&#xD;
      concentrations in the underlying cortex. Data will be stored for post processing analysis.&#xD;
&#xD;
      The main outcome measures will be: 1) a correlation of the fNIRS results between the TBI and&#xD;
      non-TBI groups; 2) a correlation of the fNIRS results with the severity of the TBI within the&#xD;
      TBI group. Finally, we plan to compare individual measurement from TBI patients with the&#xD;
      healthy group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>July 25, 2012</start_date>
  <completion_date>July 1, 2013</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma.</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome of the two parametric paradigms will investigate if the degree of disruption correlates with measures of the severity of injury (GC scale). Finally, we will compare individual measurement form TBI patient with the health...</measure>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Cognition Disorder</condition>
  <condition>Functional Brain Imaging</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Healthy population&#xD;
&#xD;
        - Age 18 to 60, inclusive.&#xD;
&#xD;
        Traumatic brain injuries population&#xD;
&#xD;
          -  Age 18 to 60.&#xD;
&#xD;
          -  Have a recorded past traumatic brain injuries rated in the Glasgow Coma Scale between&#xD;
             9 and 15&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of hypertension&#xD;
&#xD;
          -  History of any disease of the central nervous system&#xD;
&#xD;
          -  Current use of sedating medication, including antihistamines&#xD;
&#xD;
          -  Subjects with any of the following will be excluded from MRI testing: aneurysm clip;&#xD;
             implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator;&#xD;
             cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner;&#xD;
             insulin pump; or irremovable body piercing due to the possible dangerous effects of&#xD;
             the MRI magnet upon metal objects in the body.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amir Gandjbakhche, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <reference>
    <citation>Hanna-Pladdy B. Dysexecutive syndromes in neurologic disease. J Neurol Phys Ther. 2007 Sep;31(3):119-27. doi: 10.1097/NPT.0b013e31814a63c2.</citation>
    <PMID>18025957</PMID>
  </reference>
  <reference>
    <citation>Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.</citation>
    <PMID>18635021</PMID>
  </reference>
  <reference>
    <citation>Strangman GE, Goldstein R, O'Neil-Pirozzi TM, Kelkar K, Supelana C, Burke D, Katz DI, Rauch SL, Savage CR, Glenn MB. Neurophysiological alterations during strategy-based verbal learning in traumatic brain injury. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):226-36. doi: 10.1177/1545968308324225. Epub 2008 Dec 1.</citation>
    <PMID>19047359</PMID>
  </reference>
  <verification_date>July 1, 2013</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>June 30, 2017</last_update_submitted>
  <last_update_submitted_qc>June 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <keyword>Near Infrared Spectroscopy</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668758
org study id: 120165
secondary id: 12-CH-0165
nct id: NCT01668758
lead sponsor: 
Background:

      - The amount of blood flowing in brain areas goes up when those areas are being used for
      activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a
      common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also
      be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI.
      Researchers want to compare fMRI and NIRS to see whether they give similar results. These
      studies will be used to look at people who have had a traumatic brain injury.

      Objectives:

      - To test how well NIRS measure changes in blood flow in the brain after a traumatic brain
      injury.

      Eligibility:

        -  Individuals between 18 and 60 years of age who have had a traumatic brain injury.

        -  Healthy volunteers at least 18 years of age.

      Design:

        -  Participants will be screened with a physical exam and medical history. Researchers may
           ask to see brain images during from previous MRI scans.

        -  Participants will have a NIRS scan of the brain. They will be asked to do certain tasks
           while inside the scanner. These tasks will involve responding to images that appear on a
           screen.

        -  Treatment will not be provided as part of this study.
The goal of this study is to be able to assess frontal lobe function in a rapid, objective,
      and standardized way, without the need for expertise in cognitive test administration. Such
      methods would be particularly helpful in mild traumatic brain injury, where objective
      measures are needed, and would greatly expand the capacity to make such assessments in
      standard clinical practice.

      Our goal is to recruit 100 subjects total in two groups of age, gender, and education matched
      subjects, as follows: TBI (n = 50) and non-TBI (n = 50).

      The subject will be asked to perform 2 computer-based cognitive tests while the fNIRS device
      is in place. The fNIRS sensor pads will record changes in blood oxy/deoxy hemoglobin
      concentrations in the underlying cortex. Data will be stored for post processing analysis.

      The main outcome measures will be: 1) a correlation of the fNIRS results between the TBI and
      non-TBI groups; 2) a correlation of the fNIRS results with the severity of the TBI within the
      TBI group. Finally, we plan to compare individual measurement from TBI patients with the
      healthy group.
time perspective: Other
measure: The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma.
measure: The secondary outcome of the two parametric paradigms will investigate if the degree of disruption correlates with measures of the severity of injury (GC scale). Finally, we will compare individual measurement form TBI patient with the health...
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amir Gandjbakhche, Ph.D.
role: Principal Investigator
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
country: United States
citation: Hanna-Pladdy B. Dysexecutive syndromes in neurologic disease. J Neurol Phys Ther. 2007 Sep;31(3):119-27. doi: 10.1097/NPT.0b013e31814a63c2.
PMID: 18025957
citation: Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.
PMID: 18635021
citation: Strangman GE, Goldstein R, O'Neil-Pirozzi TM, Kelkar K, Supelana C, Burke D, Katz DI, Rauch SL, Savage CR, Glenn MB. Neurophysiological alterations during strategy-based verbal learning in traumatic brain injury. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):226-36. doi: 10.1177/1545968308324225. Epub 2008 Dec 1.
PMID: 19047359
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Cognition Disorders