<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/NCT03789201</url>
  </required_header>
  <id_info>
    <org_study_id>190036</org_study_id>
    <secondary_id>19-N-0036</secondary_id>
    <nct_id>NCT03789201</nct_id>
  </id_info>
  <brief_title>Exploring the Relationship Between Brain Asymmetry and Attention</brief_title>
  <official_title>Exploring the Relationship Between Brain Asymmetry and Attention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      People tend to pay more attention to one side of space than the other and this may be due to&#xD;
      differences in the structure and function of the two sides of the brain. We are interested in&#xD;
      whether we can detect those difference with magnetic resonance imaging (MRI), transcranial&#xD;
      magnetic stimulation (TMS), and electroencephalography (EEG).&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The purpose of the study is to understand how differences in brain structure may cause people&#xD;
      to pay more attention to one side than the other.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy adults ages 18-35&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with a neurological exam.&#xD;
&#xD;
      Participants will have 2-3 visits for a total duration of about 7/8 hours.&#xD;
&#xD;
      Women of childbearing age must have a negative pregnancy test before each MRI scan.&#xD;
&#xD;
      Visits may include:&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Tests of attention, and thinking&#xD;
&#xD;
      TMS. A brief electrical current will pass through a wire coil on the scalp. Participants will&#xD;
      hear a click and may feel a pull. They may be asked to tense muscles or do tasks.&#xD;
&#xD;
      Magnetic resonance imaging (MRI) scan for a maximum of 1 hour. Participants will lie on a&#xD;
      table that slides into a cylinder in a strong magnetic field. They will do tasks on a&#xD;
      computer screen or lie still. They will get earplugs for loud noise.&#xD;
&#xD;
      EEG for no longer than 5 hours, with most lasting 3 hours. Gel and a cap with electrodes will&#xD;
      be placed on the scalp. They will record brain waves while the participant gets TMS or does&#xD;
      nothing.&#xD;
&#xD;
      Questions about participants dominant hand and about the MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      The goal of this protocol to explore correlations between lateralized individual differences&#xD;
      in visual attentional preference and hemispheric asymmetries in functional connectivity&#xD;
      between the frontal and parietal visual attention areas. To measure functional connectivity,&#xD;
      resting state functional MRI and electroencephalographic (EEG) potentials evoked with&#xD;
      transcranial magnetic stimulation (TMS) will be used. Protocol research will also attempt to&#xD;
      validate the TMS-evoked EEG potentials against fMRI resting state functional connectivity.&#xD;
&#xD;
      Study Population&#xD;
&#xD;
      Up to 80 right-handed and right-eyed healthy volunteers, aged 18-35&#xD;
&#xD;
      Design&#xD;
&#xD;
      TMS evoked EEG potentials (TEPs) and fMRI will be used to measure functional connectivity&#xD;
      between the posterior parietal cortex and the frontal visual attention area. Various tasks&#xD;
      will be used to quantify attention and explore their relationship with asymmetries in&#xD;
      functional connectivity. A qualitative comparison between the value of fMRI and TEPs for&#xD;
      predicting attentional bias will be made.&#xD;
&#xD;
      Outcome Measures&#xD;
&#xD;
        -  Behavioral measures of attention&#xD;
&#xD;
        -  TEP measures of functional connectivity&#xD;
&#xD;
        -  fMRI measures of functional connectivity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">October 24, 2022</completion_date>
  <primary_completion_date type="Actual">October 24, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.</measure>
    <time_frame>20 visits</time_frame>
    <description>Response to TMS</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Normal Physiology</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>thematic permission to use non-invasive techniques regarded as having minimal risk in healthy individuals, such as, MRI, EEG, EMG, low-frequency stimulation (= 1 Hz), electrical stimulation of the skin to mimic the somatosensory artifact of TMS, and behavioral tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMS EEG</intervention_name>
    <description>attempt to use TMS EEG to measure connectivity between cortical areas</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMS fMRI</intervention_name>
    <description>compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
        For some sub-studies, we may limit participation by handedness or eye dominance.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Any current major neurological or psychiatric disorder, such as, (but not limited to)&#xD;
             stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression&#xD;
&#xD;
          -  Findings on neurological examination indicative of significant brain disease&#xD;
&#xD;
          -  Individuals with significant health problems, such as cardiovascular disease,&#xD;
             malignancy, or connective tissue disorder&#xD;
&#xD;
          -  History of seizure, defined as a diagnosis by a health care provider of one or more&#xD;
             epileptic seizures or an anecdotal history which, in the opinion of the PI, is&#xD;
             suggestive of epileptic seizure. Any individual who answers other than negatively to&#xD;
             the question, Have you ever had an epileptic seizure on screening will be questioned&#xD;
             directly by the PI&#xD;
&#xD;
          -  Current oral use of a medication that lowers the seizure threshold such as&#xD;
             neuroleptics, beta lactams, isoniazid, metronidazole, tricyclic or other&#xD;
             antidepressants, or prescription stimulants&#xD;
&#xD;
          -  Individuals regularly taking medications that cause significant psychomotor activation&#xD;
             or depression, e.g., stimulants and CNS depressant drugs such as benzodiazepines, will&#xD;
             be excluded.&#xD;
&#xD;
          -  For MRI studies: Any metal in the body which would make having an MRI scan unsafe,&#xD;
             such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses,&#xD;
             artificial heart valves, cochlear implants or shrapnel fragments, any individual who&#xD;
             was a welder or metal worker. Participants will also be excluded if they are&#xD;
             uncomfortable in small closed spaces (i.e. claustrophobia) or are not able to lie&#xD;
             comfortably on their back for up to two hours&#xD;
&#xD;
          -  Pregnancy or plans to become pregnant in the next two months&#xD;
&#xD;
          -  Members of the Behavioral Neurology Unit, NINDS&#xD;
&#xD;
          -  Use of illegal drugs in the past year&#xD;
&#xD;
          -  Consumption of more than 7 alcoholic drinks a week for females or 14 alcoholic drinks&#xD;
             a week for males.&#xD;
&#xD;
        There is no general exclusion for NIH employees. Inclusion/exclusion criteria will be&#xD;
        checked before enrollment in each sub-study to ensure that participants remain eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric M Wassermann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Neurological Disorders and Stroke (NINDS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-N-0036.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>October 24, 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TMS-Evoked Potential</keyword>
  <keyword>TMS</keyword>
  <keyword>fMRI</keyword>
  <keyword>Behavior</keyword>
  <keyword>Electroencephalogram (EEG)</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>.Data sharing at an independent subject level may not be feasible.</ipd_description>
  </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/NCT03789201
org study id: 190036
secondary id: 19-N-0036
nct id: NCT03789201
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      People tend to pay more attention to one side of space than the other and this may be due to
      differences in the structure and function of the two sides of the brain. We are interested in
      whether we can detect those difference with magnetic resonance imaging (MRI), transcranial
      magnetic stimulation (TMS), and electroencephalography (EEG).

      Objective:

      The purpose of the study is to understand how differences in brain structure may cause people
      to pay more attention to one side than the other.

      Eligibility:

      Healthy adults ages 18-35

      Design:

      Participants will be screened with a neurological exam.

      Participants will have 2-3 visits for a total duration of about 7/8 hours.

      Women of childbearing age must have a negative pregnancy test before each MRI scan.

      Visits may include:

      Physical exam

      Tests of attention, and thinking

      TMS. A brief electrical current will pass through a wire coil on the scalp. Participants will
      hear a click and may feel a pull. They may be asked to tense muscles or do tasks.

      Magnetic resonance imaging (MRI) scan for a maximum of 1 hour. Participants will lie on a
      table that slides into a cylinder in a strong magnetic field. They will do tasks on a
      computer screen or lie still. They will get earplugs for loud noise.

      EEG for no longer than 5 hours, with most lasting 3 hours. Gel and a cap with electrodes will
      be placed on the scalp. They will record brain waves while the participant gets TMS or does
      nothing.

      Questions about participants dominant hand and about the MRI.
Objective

      The goal of this protocol to explore correlations between lateralized individual differences
      in visual attentional preference and hemispheric asymmetries in functional connectivity
      between the frontal and parietal visual attention areas. To measure functional connectivity,
      resting state functional MRI and electroencephalographic (EEG) potentials evoked with
      transcranial magnetic stimulation (TMS) will be used. Protocol research will also attempt to
      validate the TMS-evoked EEG potentials against fMRI resting state functional connectivity.

      Study Population

      Up to 80 right-handed and right-eyed healthy volunteers, aged 18-35

      Design

      TMS evoked EEG potentials (TEPs) and fMRI will be used to measure functional connectivity
      between the posterior parietal cortex and the frontal visual attention area. Various tasks
      will be used to quantify attention and explore their relationship with asymmetries in
      functional connectivity. A qualitative comparison between the value of fMRI and TEPs for
      predicting attentional bias will be made.

      Outcome Measures

        -  Behavioral measures of attention

        -  TEP measures of functional connectivity

        -  fMRI measures of functional connectivity
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Exploratory sub-studies under this protocol will answer questions about how to optimize EEG recordings of the cortical response to TMS.
time frame: 20 visits
description: Response to TMS
arm group label: Healthy Volunteers
arm group type: Experimental
description: thematic permission to use non-invasive techniques regarded as having minimal risk in healthy individuals, such as, MRI, EEG, EMG, low-frequency stimulation (= 1 Hz), electrical stimulation of the skin to mimic the somatosensory artifact of TMS, and behavioral tests
intervention type: Device
intervention name: TMS EEG
description: attempt to use TMS EEG to measure connectivity between cortical areas
arm group label: Healthy Volunteers
intervention type: Device
intervention name: TMS fMRI
description: compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI
arm group label: Healthy Volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric M Wassermann, M.D.
role: Principal Investigator
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-N-0036.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: .Data sharing at an independent subject level may not be feasible.