<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/NCT01692561</url>
  </required_header>
  <id_info>
    <org_study_id>WFMCMRI 001</org_study_id>
    <secondary_id>JEF MRI 001</secondary_id>
    <nct_id>NCT01692561</nct_id>
  </id_info>
  <brief_title>MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters</brief_title>
  <official_title>Study Title: Brain Transmitters/Metabolites, Magnetic Resonance Spectroscopy, and Brain Connectivity: Diagnostic Strategies to Study the Effects of Non-Pharmacologic Therapies for Dysautonomia and Chronic Nausea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to better understand what causes dysautonomia and how&#xD;
      this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous&#xD;
      system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms&#xD;
      of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of&#xD;
      anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic&#xD;
      tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to&#xD;
      standing, called orthostatic intolerance. We would like to learn more about the link between&#xD;
      orthostatic intolerance and nausea. While medications currently used to treat orthostatic&#xD;
      intolerance and nausea have proven to be effective in some patients, this may not be the best&#xD;
      treatment for everyone as long term use could pose certain risks including high blood&#xD;
      pressure. In order to provide a more focused and safer treatment for patients suffering from&#xD;
      nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and&#xD;
      certain blood tests change during a tilt table test. This test helps to create the same&#xD;
      circumstances that patients with orthostatic intolerance experience when they stand. To&#xD;
      better understand if some of these problems are associated with the brain, we will study MRI&#xD;
      in patients with dysautonomia compared to children without dysautonomia. This information may&#xD;
      allow us to use alternative and safer treatments in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">June 11, 2013</completion_date>
  <primary_completion_date type="Actual">June 11, 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the implication of dysautonomia on the brain and better evaluate its potential mechanistic process.</measure>
    <time_frame>Assessments will occur in a one and a half hour visit.</time_frame>
    <description>The first objective of the proposed project is to study central transmitter/metabolite profiles using in vivo 1H Magnetic Resonance Spectroscopy (MRS) in children with dysautonomia diagnosed by tilt table testing compared to healthy children without symptoms of dysautonomia. The second objective will be to determine whether dysautonomia associated with nausea and cardiovascular instability shares common alterations in brain networks. We will be using cognitive and sensory processing tasks based on our prior experience with both traditional fMRI and network analyses.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Dysautonomia</condition>
  <arm_group>
    <arm_group_label>normaL</arm_group_label>
    <description>Healthy subjects without symptoms of dysautonomia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neurocardiogenic syncope</arm_group_label>
    <description>Fainting due to sudden drop in blood pressure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthostatic hypotension</arm_group_label>
    <description>Sudden decrease in blood pressure while standing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postural Orthostatic Tachycardic Syndrome</arm_group_label>
    <description>Increased heart rate when standing.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A combination of male and female subjects who are healthy or ahve dysautonomia/&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects who have completed tilt autonomic testing&#xD;
&#xD;
          -  subjects from 9 - 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who have a metabolic, mechanical, or mucosal inflammatory cause which has&#xD;
             been defined to explain their gastrointestinal symptoms&#xD;
&#xD;
          -  Patients with cardiac or cardiovascular disease, malignancy, psychiatric illness,&#xD;
             neurodevelopmental delay, or other co-morbid conditions&#xD;
&#xD;
          -  Patients with with pacemakers, implanted devices, or any other MRI contraindications&#xD;
             will be excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Debra Diz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dysautonomia</keyword>
  <keyword>Postural orthostatic tachycardic hypotension</keyword>
  <keyword>Neurocardiogenic vasovagal syncope</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Dysautonomias</mesh_term>
    <mesh_term>Autonomic Nervous System Diseases</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/NCT01692561
org study id: WFMCMRI 001
secondary id: JEF MRI 001
nct id: NCT01692561
lead sponsor: 
has dmc: Yes
The purpose of this research study is to better understand what causes dysautonomia and how
      this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous
      system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms
      of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of
      anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic
      tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to
      standing, called orthostatic intolerance. We would like to learn more about the link between
      orthostatic intolerance and nausea. While medications currently used to treat orthostatic
      intolerance and nausea have proven to be effective in some patients, this may not be the best
      treatment for everyone as long term use could pose certain risks including high blood
      pressure. In order to provide a more focused and safer treatment for patients suffering from
      nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and
      certain blood tests change during a tilt table test. This test helps to create the same
      circumstances that patients with orthostatic intolerance experience when they stand. To
      better understand if some of these problems are associated with the brain, we will study MRI
      in patients with dysautonomia compared to children without dysautonomia. This information may
      allow us to use alternative and safer treatments in the future.
observational model: Case-Control
time perspective: Prospective
measure: Assessment of the implication of dysautonomia on the brain and better evaluate its potential mechanistic process.
time frame: Assessments will occur in a one and a half hour visit.
description: The first objective of the proposed project is to study central transmitter/metabolite profiles using in vivo 1H Magnetic Resonance Spectroscopy (MRS) in children with dysautonomia diagnosed by tilt table testing compared to healthy children without symptoms of dysautonomia. The second objective will be to determine whether dysautonomia associated with nausea and cardiovascular instability shares common alterations in brain networks. We will be using cognitive and sensory processing tasks based on our prior experience with both traditional fMRI and network analyses.
arm group label: normaL
description: Healthy subjects without symptoms of dysautonomia.
arm group label: Neurocardiogenic syncope
description: Fainting due to sudden drop in blood pressure.
arm group label: Orthostatic hypotension
description: Sudden decrease in blood pressure while standing.
arm group label: Postural Orthostatic Tachycardic Syndrome
description: Increased heart rate when standing.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Debra Diz, M.D.
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Primary Dysautonomias
mesh term: Autonomic Nervous System Diseases