<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/NCT03232723</url>
  </required_header>
  <id_info>
    <org_study_id>17-00684</org_study_id>
    <nct_id>NCT03232723</nct_id>
  </id_info>
  <brief_title>Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG</brief_title>
  <acronym>BODMEG</acronym>
  <official_title>Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine the effectiveness of the&#xD;
      Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body&#xD;
      other than the brain. This study will examine if electrical activity from parts of the body,&#xD;
      other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies&#xD;
      of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which&#xD;
      can be severe, yet there is no non-invasive way to image this abnormal activity. This is&#xD;
      particularly relevant to deep muscle pain and back pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">September 7, 2017</completion_date>
  <primary_completion_date type="Actual">September 7, 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of optimal position to obtain safe and effective imaging of structures other than the brain.</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Hand position 1 relaxed&#xD;
Hand position 1 muscles active&#xD;
Hand position 2 relaxed&#xD;
Hand position 2 muscles active&#xD;
Neck and Jaw, relaxed&#xD;
Neck and Jaw, tensed&#xD;
Upper torso relaxed&#xD;
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evoked activity to obtain safe and effective imaging of structures other than the brain</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Hand position 1 relaxed&#xD;
Hand position 1 muscles active&#xD;
Hand position 2 relaxed&#xD;
Hand position 2 muscles active&#xD;
Neck and Jaw, relaxed&#xD;
Neck and Jaw, tensed&#xD;
Upper torso relaxed&#xD;
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dominant frequency of non-brain electrical activity in healthy adults.</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Hand position 1 relaxed&#xD;
Hand position 1 muscles active&#xD;
Hand position 2 relaxed&#xD;
Hand position 2 muscles active&#xD;
Neck and Jaw, relaxed&#xD;
Neck and Jaw, tensed&#xD;
Upper torso relaxed&#xD;
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of non-brain of activity in healthy adults.</measure>
    <time_frame>2 Weeks</time_frame>
    <description>Hand position 1 relaxed&#xD;
Hand position 1 muscles active&#xD;
Hand position 2 relaxed&#xD;
Hand position 2 muscles active&#xD;
Neck and Jaw, relaxed&#xD;
Neck and Jaw, tensed&#xD;
Upper torso relaxed&#xD;
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)&#xD;
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>MEG Recording</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Magnetic fields will be recorded using a 275-channel whole-head MEG system</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Whole-cortex MEG System (with optional EEG)</intervention_name>
    <description>&quot;Whole-Cortex MEG System&quot; non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain.</description>
    <arm_group_label>MEG Recording</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults who are willing and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with characteristics incompatible with MEG recordings as listed on the MEG&#xD;
             Safety checklist (Appendix A),&#xD;
&#xD;
          -  Involuntary, uncontrolled tremor,&#xD;
&#xD;
          -  chronic pain.&#xD;
&#xD;
          -  pregnant women (based on self-report).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodolfo Llinas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetoencephalography</keyword>
  <keyword>Whole-cortex MEG System (with optional EEG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03232723
org study id: 17-00684
nct id: NCT03232723
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary purpose of this study is to determine the effectiveness of the
      Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body
      other than the brain. This study will examine if electrical activity from parts of the body,
      other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies
      of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which
      can be severe, yet there is no non-invasive way to image this abnormal activity. This is
      particularly relevant to deep muscle pain and back pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Determination of optimal position to obtain safe and effective imaging of structures other than the brain.
time frame: 2 Weeks
description: Hand position 1 relaxed
Hand position 1 muscles active
Hand position 2 relaxed
Hand position 2 muscles active
Neck and Jaw, relaxed
Neck and Jaw, tensed
Upper torso relaxed
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
measure: Evoked activity to obtain safe and effective imaging of structures other than the brain
time frame: 2 Weeks
description: Hand position 1 relaxed
Hand position 1 muscles active
Hand position 2 relaxed
Hand position 2 muscles active
Neck and Jaw, relaxed
Neck and Jaw, tensed
Upper torso relaxed
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
measure: Dominant frequency of non-brain electrical activity in healthy adults.
time frame: 2 Weeks
description: Hand position 1 relaxed
Hand position 1 muscles active
Hand position 2 relaxed
Hand position 2 muscles active
Neck and Jaw, relaxed
Neck and Jaw, tensed
Upper torso relaxed
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
measure: Location of non-brain of activity in healthy adults.
time frame: 2 Weeks
description: Hand position 1 relaxed
Hand position 1 muscles active
Hand position 2 relaxed
Hand position 2 muscles active
Neck and Jaw, relaxed
Neck and Jaw, tensed
Upper torso relaxed
Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
arm group label: MEG Recording
arm group type: Other
description: Magnetic fields will be recorded using a 275-channel whole-head MEG system
intervention type: Diagnostic Test
intervention name: Whole-cortex MEG System (with optional EEG)
description: "Whole-Cortex MEG System" non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain.
arm group label: MEG Recording
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rodolfo Llinas, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: Undecided