<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/NCT03244501</url>
  </required_header>
  <id_info>
    <org_study_id>17-1022</org_study_id>
    <nct_id>NCT03244501</nct_id>
  </id_info>
  <brief_title>Transcranial Static Magnetic Field Stimulation of Frontal Cortex</brief_title>
  <official_title>Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if a new brain stimulation technique, static magnetic&#xD;
      field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp,&#xD;
      can influence normal rhythms of brain activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator's primary objective is to determine the feasibility of modifying frontal&#xD;
      brain activity using static magnetic fields. The investigator's will be examining the effects&#xD;
      of static magnetic field of the spectral power of EEG data with healthy human participants.&#xD;
&#xD;
      This is a within-subjects design, where each participant will receive sham and active&#xD;
      stimulation on the left and right frontal cortex. EEG data will be collected during each&#xD;
      stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for providing the study coordinator with the active and sham magnet sequence. Each magnet has a number; the study coordinator is not aware which number corresponds to active or sham magnets.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Electroencephalogram (EEG) Spectral Power</measure>
    <time_frame>4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation</time_frame>
    <description>Changes in the spectral power of the EEG before (2 min eyes-closed, 2 min eyes-open), during (eyes-open), and after stimulation (eyes-open)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation</time_frame>
    <description>Change in the ratio between the power in low frequency band and the power in high frequency band. As this outcome variable is a ratio between two items that are measured in microvolt^2, the ratio does not have a unit of measure.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Left Frontal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An active magnet (active tSMS) will be placed over the left frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the right frontal cortex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right Frontal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An active magnet (active tSMS) will be placed over the right frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left frontal cortex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Frontal</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active tSMS</intervention_name>
    <description>A cylindrical neodymium magnet is placed above the scalp.</description>
    <arm_group_label>Left Frontal</arm_group_label>
    <arm_group_label>Right Frontal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham tSMS</intervention_name>
    <description>A cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets.</description>
    <arm_group_label>Sham Frontal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right-handed, healthy, 18+ years old&#xD;
&#xD;
          -  Capacity to understand all relevant risks and potential benefits of the study&#xD;
             (informed consent)&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study - Speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of Psychological/Emotional Disorders (depression, anxiety, bipolar,&#xD;
             etc.)&#xD;
&#xD;
          -  (For females) Pregnancy or breast feeding&#xD;
&#xD;
          -  Diagnosis of eating disorder (current or within the past 6 months)&#xD;
&#xD;
          -  Diagnosis of Obsessive-Compulsive Disorder (lifetime) Attention Deficit Hyperactivity&#xD;
             Disorder (currently under treatment)&#xD;
&#xD;
          -  Neurological disorders and conditions, including, but not limited to:&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  Seizures (except childhood febrile seizures and Electroconvulsive therapy-induced&#xD;
             seizures)&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  History of stroke&#xD;
&#xD;
          -  Parkinson's disease&#xD;
&#xD;
          -  Multiple sclerosis&#xD;
&#xD;
          -  Cerebral aneurysm&#xD;
&#xD;
          -  Brain tumors&#xD;
&#xD;
          -  Medical or neurological illness or treatment for a medical disorder that could&#xD;
             interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS,&#xD;
             malignancy, liver or renal impairment)&#xD;
&#xD;
          -  Prior brain surgery Any brain devices/implants, including cochlear implants and&#xD;
             aneurysm clips&#xD;
&#xD;
          -  Any metal in/on the body, e.g., dental braces, glasses, piercings&#xD;
&#xD;
          -  Traumatic brain injury&#xD;
&#xD;
          -  Thick hair that would create distance between the magnet and the scalp&#xD;
&#xD;
          -  Taking hormonal birth control or hormonal supplements (e.g., testosterone injections)&#xD;
             - Anything that, in the opinion of the investigator, would place the participant at&#xD;
             increased risk or preclude the participant's full compliance with or completion of the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Flavio Frohlich, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tSMS</keyword>
  <keyword>Transcranial Static Magnetic Field Stimulation</keyword>
  <keyword>healthy control</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/NCT03244501
org study id: 17-1022
nct id: NCT03244501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see if a new brain stimulation technique, static magnetic
      field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp,
      can influence normal rhythms of brain activity.
The investigator's primary objective is to determine the feasibility of modifying frontal
      brain activity using static magnetic fields. The investigator's will be examining the effects
      of static magnetic field of the spectral power of EEG data with healthy human participants.

      This is a within-subjects design, where each participant will receive sham and active
      stimulation on the left and right frontal cortex. EEG data will be collected during each
      stimulation.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for providing the study coordinator with the active and sham magnet sequence. Each magnet has a number; the study coordinator is not aware which number corresponds to active or sham magnets.
measure: Electroencephalogram (EEG) Spectral Power
time frame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
description: Changes in the spectral power of the EEG before (2 min eyes-closed, 2 min eyes-open), during (eyes-open), and after stimulation (eyes-open)
measure: Heart Rate Variability
time frame: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
description: Change in the ratio between the power in low frequency band and the power in high frequency band. As this outcome variable is a ratio between two items that are measured in microvolt^2, the ratio does not have a unit of measure.
arm group label: Left Frontal
arm group type: Experimental
description: An active magnet (active tSMS) will be placed over the left frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the right frontal cortex.
arm group label: Right Frontal
arm group type: Experimental
description: An active magnet (active tSMS) will be placed over the right frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left frontal cortex.
arm group label: Sham Frontal
arm group type: Sham Comparator
description: Sham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex.
intervention type: Other
intervention name: Active tSMS
description: A cylindrical neodymium magnet is placed above the scalp.
arm group label: Left Frontal
arm group label: Right Frontal
intervention type: Other
intervention name: Sham tSMS
description: A cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets.
arm group label: Sham Frontal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Flavio Frohlich, PhD
role: Study Director
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor