<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/NCT04506892</url>
  </required_header>
  <id_info>
    <org_study_id>RFA-AT-21-001</org_study_id>
    <nct_id>NCT04506892</nct_id>
  </id_info>
  <brief_title>Quantitation of Glymphatic Functioning in Sleep and Meditative States</brief_title>
  <official_title>Quantitation of Glymphatic Functioning in Sleep and Meditative States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This involves development and application of magnetic resonance imaging (MRI) methods for&#xD;
      visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced&#xD;
      meditation experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is evaluating the glymphatic system during awake, sleep, and meditative states.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">July 2027</completion_date>
  <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking is used in this protocol</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CSF flow change</measure>
    <time_frame>baseline to 24 hours</time_frame>
    <description>Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EEG changes</measure>
    <time_frame>baseline to 24 hours</time_frame>
    <description>Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Adept Meditators</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meditation</intervention_name>
    <description>meditation</description>
    <arm_group_label>Adept Meditators</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 14-45&#xD;
&#xD;
          -  &quot;Adept meditator status&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any non-MR compatible material implant, or contraindication to MR scanning&#xD;
&#xD;
          -  Claustrophobia or inability to lie still for prolonged periods of time&#xD;
&#xD;
          -  Participants with a recent (less than 2 months) infection, tattoo, or wound&#xD;
&#xD;
          -  No consumption of stimulants or alcohol within 12 hours of the study visit&#xD;
&#xD;
          -  clinical diagnosis of any major neurological or psychological condition&#xD;
&#xD;
          -  Taking benzodiazepines, cholinestorase inhibitors, anti-psychotics, opioids, MAO&#xD;
             inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Claassen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Claassen, MD</last_name>
    <phone>6153226103</phone>
    <email>daniel.claassen@vumc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Garza, MS</last_name>
    <email>maria.e.garza@vumc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212-3160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Daniel Claassen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>glymphatic system</keyword>
  <keyword>meditation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT04506892
org study id: RFA-AT-21-001
nct id: NCT04506892
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This involves development and application of magnetic resonance imaging (MRI) methods for
      visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced
      meditation experience.
This study is evaluating the glymphatic system during awake, sleep, and meditative states.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
masking description: no masking is used in this protocol
measure: CSF flow change
time frame: baseline to 24 hours
description: Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states
measure: EEG changes
time frame: baseline to 24 hours
description: Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.
arm group label: Adept Meditators
arm group type: Experimental
description: Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.
intervention type: Behavioral
intervention name: Meditation
description: meditation
arm group label: Adept Meditators
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Claassen, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Daniel Claassen, MD
phone: 6153226103
email: daniel.claassen@vumc.org
last name: Maria Garza, MS
email: maria.e.garza@vumc.org
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Daniel Claassen
investigator title: Associate Professor
mesh term: Parkinson Disease