<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/NCT04464265</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00176300</org_study_id>
    <secondary_id>R01GM103894</secondary_id>
    <nct_id>NCT04464265</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia</brief_title>
  <official_title>Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to better understand the systems-level neuronal mechanisms by which general&#xD;
      anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress&#xD;
      consciousness by disrupting the functioning of large-scale brain networks that support&#xD;
      information integration in the brain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2021</start_date>
  <completion_date type="Actual">August 5, 2022</completion_date>
  <primary_completion_date type="Actual">August 5, 2022</primary_completion_date>
  <phase>Phase 4</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>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Oxygen Level Dependent (BOLD) Response to sensory stimuli during sedation</measure>
    <time_frame>Up to 90 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Squeeze Pressure</measure>
    <time_frame>Up to 90 minutes</time_frame>
    <description>Measurement of force of participants' hand squeezing on a rubber ball in response to instructions. This will be measured in millimeters of mercury (mmHg) of air pressure during squeezing the rubber ball, using BIOPAC (https://www.biopac.com) MP160 system with AcqKnowledge software (V5.0).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Functional Magnetic Resonance Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>While music is played Noninvasive functional magnetic resonance (fMRI) imaging will be performed at the University of Michigan Health System, University Hospital, Department of Radiology.&#xD;
The fMRI is done under anesthesia using propofol. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations of 1.2, 1.6, 2.0, and 2.4 μg/ml in a stepwise fashion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Magnetic Resonance Imaging (fMRI)</intervention_name>
    <description>Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.&#xD;
Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word &quot;squeeze&quot;.</description>
    <arm_group_label>Functional Magnetic Resonance Imaging</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy,&#xD;
             non-smoking, no or minimal alcohol use&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Body mass index (BMI) of less than 30&#xD;
&#xD;
          -  English speakers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical contraindication to Magnetic Resonance Imaging (MRI) scanning&#xD;
&#xD;
          -  Unable to undergo MRI scanning because of possible pregnancy&#xD;
&#xD;
          -  BMI over 30&#xD;
&#xD;
          -  Tattoos in the head or neck region&#xD;
&#xD;
          -  Unwilling to abstain from alcohol for 24 hours prior to dosing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Hudetz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Anthony G Hudetz</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Music</keyword>
  <keyword>Propofol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 23, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04464265/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 3, 2023</submitted>
    <returned>August 24, 2023</returned>
    <submitted>August 29, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04464265
org study id: HUM00176300
secondary id: R01GM103894
nct id: NCT04464265
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This study is to better understand the systems-level neuronal mechanisms by which general
      anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress
      consciousness by disrupting the functioning of large-scale brain networks that support
      information integration in the brain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Blood Oxygen Level Dependent (BOLD) Response to sensory stimuli during sedation
time frame: Up to 90 minutes
measure: Squeeze Pressure
time frame: Up to 90 minutes
description: Measurement of force of participants' hand squeezing on a rubber ball in response to instructions. This will be measured in millimeters of mercury (mmHg) of air pressure during squeezing the rubber ball, using BIOPAC (https://www.biopac.com) MP160 system with AcqKnowledge software (V5.0).
arm group label: Functional Magnetic Resonance Imaging
arm group type: Experimental
description: While music is played Noninvasive functional magnetic resonance (fMRI) imaging will be performed at the University of Michigan Health System, University Hospital, Department of Radiology.
The fMRI is done under anesthesia using propofol. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations of 1.2, 1.6, 2.0, and 2.4 μg/ml in a stepwise fashion.
intervention type: Other
intervention name: Functional Magnetic Resonance Imaging (fMRI)
description: Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.
Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word "squeeze".
arm group label: Functional Magnetic Resonance Imaging
other name: Diprivan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anthony Hudetz, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Anthony G Hudetz
investigator title: Professor of Anesthesiology
mesh term: Propofol
sharing ipd: No
provided document: 
submitted: August 3, 2023
returned: August 24, 2023
submitted: August 29, 2023