<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01712633</url>
  </required_header>
  <id_info>
    <org_study_id>130003</org_study_id>
    <secondary_id>13-CC-0003</secondary_id>
    <nct_id>NCT01712633</nct_id>
  </id_info>
  <brief_title>Tests of Functional Magnetic Resonance Imaging Techniques</brief_title>
  <official_title>Imaging Techniques in fMRI and fMRI Reproducibility: An NIH/FDA Interagency Collaboration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series&#xD;
      of pictures that can be used to look at how the brain processes information. It is used to&#xD;
      study problems with thinking, language, and movement, among other things. Researchers are&#xD;
      working to develop new and better fMRI techniques. To test these techniques, they want to&#xD;
      perform fMRI scans on healthy volunteers.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To test different fMRI techniques in healthy volunteers.&#xD;
&#xD;
      Eligibility:&#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.&#xD;
&#xD;
        -  Participants will have fMRI scans of the brain. During these scans, they will be asked&#xD;
           to perform simple tasks. These tasks may involve language, thinking, or motor skills.&#xD;
           The scanning sessions will last up to 2 hours.&#xD;
&#xD;
        -  Participants may be asked to return for additional fMRI scans over several years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional magnetic resonance imaging (fMRI) is a non invasive imaging technique that enables&#xD;
      scientists to understand the biological basis of higher order cognitive functioning such as&#xD;
      emotions, attention, language and visual processing. It has been used as a research tool&#xD;
      since the 1980 s. Recently, fMRI has received approval by the Center for Medicare and&#xD;
      Medicaid Services (CMS) to be used clinically which we believe will drastically increase its&#xD;
      use in clinical decision making by physicians in the very near future. However, currently&#xD;
      implemented imaging techniques have technical and physiologic limitations such as&#xD;
      susceptibility artifacts, image distortions, physiological noise, and MRI induced energy&#xD;
      deposition from radiomagnetic waves typically used in fMRI acquisitions that may potentially&#xD;
      reduce the clinical effectiveness of this imaging modality. This protocol is a unique&#xD;
      technical development pilot study being conducted jointly by researchers at the National&#xD;
      Institutes of Health (NIH) and the US Food and Drug Administration (FDA) to evaluate the&#xD;
      performance of physiologic and technical factors of fMRI imaging methods and equipment that&#xD;
      may affect image quality, reproducibility, and reliability in the clinical setting. These&#xD;
      studies are an important basis upon which improved regulatory evaluation of new functional&#xD;
      imaging technologies can be performed as these technologies become increasingly used in&#xD;
      patient care in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Changes to funding&#xD;
  </why_stopped>
  <start_date type="Actual">March 19, 2015</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of fMRI techniques</measure>
    <time_frame>Study day 1, followup visit(s)</time_frame>
    <description>To test different fMRI techniques in healthy volunteers.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthly Volunteers</condition>
  <arm_group>
    <arm_group_label>Volunteers</arm_group_label>
    <description>Healthy Volunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers willing to come to NIH or are already part of an existing NIH protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Healthy volunteers, new or from current NIH protocols are eligible. Healthy volunteers&#xD;
             will be defined according the history obtained from reported medical history, medical&#xD;
             record (reported at registration), the MRI safety questionnaire, and a clinical grade&#xD;
             noncontrast brain MRI.&#xD;
&#xD;
          -  Willing to travel to the NIH for follow-up visits&#xD;
&#xD;
          -  Greater than 18 years old&#xD;
&#xD;
          -  Able to understand and sign informed consent.&#xD;
&#xD;
          -  Bilingual or multilingual subjects can participate in this study as long as the&#xD;
             subjects are also fluent in English. Subjects do not need to be native or monolingual&#xD;
             speakers of English.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        The following criteria will be used to exclude subjects from participating in this&#xD;
        protocol:&#xD;
&#xD;
          -  Implanted metal clips or wires of the type which may concentrate radiofrequency fields&#xD;
             or cause tissue damages from twisting in a Magnetic field. Examples:&#xD;
&#xD;
               -  Aneurysm clip, implanted neural stimulator,&#xD;
&#xD;
               -  Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical&#xD;
                  or metallic devices,&#xD;
&#xD;
               -  Cochlear implant, ocular foreign body (metal shavings),&#xD;
&#xD;
               -  Any implanted device (pumps, infusion devices, etc.),&#xD;
&#xD;
               -  Shrapnel injuries,&#xD;
&#xD;
               -  History of metal in head or eyes or other parts of the body.&#xD;
&#xD;
               -  Vagus Nerve Stimulators (VNS)&#xD;
&#xD;
               -  Subjects with tattoos that contain metal.&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Over 350 lbs because of the weight limit of the MRI table&#xD;
&#xD;
          -  Prior surgery that may render performing the MRI to be unsafe.&#xD;
&#xD;
          -  Untreatable claustrophobia otherwise requiring anesthesia or antianxiety medications&#xD;
             that may alter the subject s ability to perform the tasks during fMRI scanning.&#xD;
&#xD;
          -  Subjects will be asked to refrain from drinking or eating caffeinated foods or drinks&#xD;
             the morning of the scan that can result in vessel vasoconstriction prior to the scan.&#xD;
&#xD;
          -  Any contraindications that the Physician identifies from the Subject s reported&#xD;
             history, MRI Safety Questionnaire and/or medical record.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia M Biassou, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2013-CC-0003.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Hennig J, Speck O, Koch MA, Weiller C. Functional magnetic resonance imaging: a review of methodological aspects and clinical applications. J Magn Reson Imaging. 2003 Jul;18(1):1-15. doi: 10.1002/jmri.10330.</citation>
    <PMID>12815634</PMID>
  </reference>
  <reference>
    <citation>Bennett CM, Miller MB. How reliable are the results from functional magnetic resonance imaging? Ann N Y Acad Sci. 2010 Mar;1191:133-55. doi: 10.1111/j.1749-6632.2010.05446.x.</citation>
    <PMID>20392279</PMID>
  </reference>
  <reference>
    <citation>Pillai JJ. The evolution of clinical functional imaging during the past 2 decades and its current impact on neurosurgical planning. AJNR Am J Neuroradiol. 2010 Feb;31(2):219-25. doi: 10.3174/ajnr.A1845.</citation>
    <PMID>20150316</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fMRI</keyword>
  <keyword>Brain Perfusion</keyword>
  <!-- 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/NCT01712633
org study id: 130003
secondary id: 13-CC-0003
nct id: NCT01712633
lead sponsor: 
Background:

      - Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series
      of pictures that can be used to look at how the brain processes information. It is used to
      study problems with thinking, language, and movement, among other things. Researchers are
      working to develop new and better fMRI techniques. To test these techniques, they want to
      perform fMRI scans on healthy volunteers.

      Objectives:

      - To test different fMRI techniques in healthy volunteers.

      Eligibility:

      - Healthy volunteers at least 18 years of age.

      Design:

        -  Participants will be screened with a physical exam and medical history.

        -  Participants will have fMRI scans of the brain. During these scans, they will be asked
           to perform simple tasks. These tasks may involve language, thinking, or motor skills.
           The scanning sessions will last up to 2 hours.

        -  Participants may be asked to return for additional fMRI scans over several years.
Functional magnetic resonance imaging (fMRI) is a non invasive imaging technique that enables
      scientists to understand the biological basis of higher order cognitive functioning such as
      emotions, attention, language and visual processing. It has been used as a research tool
      since the 1980 s. Recently, fMRI has received approval by the Center for Medicare and
      Medicaid Services (CMS) to be used clinically which we believe will drastically increase its
      use in clinical decision making by physicians in the very near future. However, currently
      implemented imaging techniques have technical and physiologic limitations such as
      susceptibility artifacts, image distortions, physiological noise, and MRI induced energy
      deposition from radiomagnetic waves typically used in fMRI acquisitions that may potentially
      reduce the clinical effectiveness of this imaging modality. This protocol is a unique
      technical development pilot study being conducted jointly by researchers at the National
      Institutes of Health (NIH) and the US Food and Drug Administration (FDA) to evaluate the
      performance of physiologic and technical factors of fMRI imaging methods and equipment that
      may affect image quality, reproducibility, and reliability in the clinical setting. These
      studies are an important basis upon which improved regulatory evaluation of new functional
      imaging technologies can be performed as these technologies become increasingly used in
      patient care in the future.
observational model: Cohort
time perspective: Prospective
measure: evaluation of fMRI techniques
time frame: Study day 1, followup visit(s)
description: To test different fMRI techniques in healthy volunteers.
arm group label: Volunteers
description: Healthy Volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Nadia M Biassou, M.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2013-CC-0003.html
description: NIH Clinical Center Detailed Web Page
citation: Hennig J, Speck O, Koch MA, Weiller C. Functional magnetic resonance imaging: a review of methodological aspects and clinical applications. J Magn Reson Imaging. 2003 Jul;18(1):1-15. doi: 10.1002/jmri.10330.
PMID: 12815634
citation: Bennett CM, Miller MB. How reliable are the results from functional magnetic resonance imaging? Ann N Y Acad Sci. 2010 Mar;1191:133-55. doi: 10.1111/j.1749-6632.2010.05446.x.
PMID: 20392279
citation: Pillai JJ. The evolution of clinical functional imaging during the past 2 decades and its current impact on neurosurgical planning. AJNR Am J Neuroradiol. 2010 Feb;31(2):219-25. doi: 10.3174/ajnr.A1845.
PMID: 20150316
responsible party type: Sponsor