<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/NCT03307317</url>
  </required_header>
  <id_info>
    <org_study_id>180001</org_study_id>
    <secondary_id>18-CH-0001</secondary_id>
    <nct_id>NCT03307317</nct_id>
  </id_info>
  <brief_title>Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder</brief_title>
  <official_title>Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</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 show changes in brain activity when they watch other people do actions. This may be&#xD;
      part of early social and communication skills. Researchers want to understand the stages of&#xD;
      normal development of motor observation and imitation in people and how it relates to social&#xD;
      development in infants and toddlers.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study the nature of brain activity that underlies typical brain functioning in infants,&#xD;
      toddlers, and adults.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Infants ages 9 12 months&#xD;
&#xD;
      Healthy adults ages 18 65&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Adult participants will have one visit. They will:&#xD;
&#xD;
      Answer questions about their family, like its size and ethnicity.&#xD;
&#xD;
      Answer questions about their own behavior and do a simple motor task.&#xD;
&#xD;
      Have EEG/fNIRS. A damp elastic cap with small sensors will be placed on the head.&#xD;
      Participants will observe stimuli, either on a video screen or of a live person. The sensors&#xD;
      will be connected to a computer. That will record the participant s brain activity while&#xD;
      watching pictures on a screen.&#xD;
&#xD;
      Infant participants will have 2 visits.&#xD;
&#xD;
      Their parents will answer questions about their family.&#xD;
&#xD;
      The parents will fill out forms about their child s development. These will be mailed to them&#xD;
      before each visit.&#xD;
&#xD;
      Parents will stay with their infant while study staff does an assessment of the child s&#xD;
      communication, motor, and thinking skills.&#xD;
&#xD;
      Infants will have EEG/fNIRS.&#xD;
&#xD;
      Infants who are at risk for developmental delays will come back for another visit when they&#xD;
      are about 2 years old. This will repeat the infant visits but it will not include EEG/fNIRS.&#xD;
&#xD;
      Some questionnaires and assessments will be videotaped.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: This investigation has two main objectives: 1) combine two child-friendly brain&#xD;
      imaging techniques and stochastic modeling to determine the neural basis for the development&#xD;
      of imitation and mimicry in human infants and 2) use machine learning to identify brain&#xD;
      activation patterns that predict impairment in imitation and mimicry in infants at risk for&#xD;
      social communication disorders.&#xD;
&#xD;
      Study Population: This study will focus on two groups of infants. The first group includes 60&#xD;
      typically developing infants, who will complete the imitation and neuroimaging paradigm&#xD;
      between the ages of 9-12 months (+/- 2 weeks) and again at 12 months of age&#xD;
&#xD;
      (+/- 2 weeks). The second group includes 60 infants at increased risk for social&#xD;
      communication disorders, including those with motor delay, language delay, preterm birth, or&#xD;
      a sibling with an autism spectrum disorder. These infants will complete the imitation and&#xD;
      neuroimaging paradigm at 12 months of age (+/- 1 month) as well as a follow up evaluation of&#xD;
      social communication skills and developmental status at 24 months of age (+/- 1 month).&#xD;
&#xD;
      Design: We propose to conduct longitudinal studies of changes in EEG and fNIRS correlates of&#xD;
      mirror neuron network activity in typical development and infants at risk for social&#xD;
      communication delay. We will measure both EEG mu suppression and hemodynamic change over the&#xD;
      motor cortex during an established infant action/observation paradigm. At all study visits,&#xD;
      infants will also complete developmental assessments that measure abilities in cognitive,&#xD;
      motor, language, and social domains.&#xD;
&#xD;
      Outcome measures: Both neuroimaging measures and developmental status will serve as outcomes&#xD;
      for this study. For the typically developing infants, change in the neuroimaging metrics&#xD;
      (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to&#xD;
&#xD;
      characterize development of the mirror neuron system, while the relation between neuroimaging&#xD;
      variables, their trajectories, and developmental ability will be used to develop hypotheses&#xD;
      about the role of the mirror neuron network in development of social communication skills.&#xD;
      For the infants at risk for social communication disorders, the main outcome will be&#xD;
      developmental status, with neuroimaging metrics used as predictors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 2, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Developmental level</measure>
    <time_frame>Visit 2 for AR group</time_frame>
    <description>Diagnostic status and behavioral scales that reflect child development at different levels: gross motor, fine motor, language and visual reception.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic response function and mu suppression</measure>
    <time_frame>Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants</time_frame>
    <description>The change in neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to characterize the development of the mirror neuron system.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Developmental Delay</condition>
  <arm_group>
    <arm_group_label>Adult pilots</arm_group_label>
    <description>Healthy adults between the ages of 18-65 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR infants</arm_group_label>
    <description>Infants with 12 months of age (+/- 2 weeks) with one of the following: observed developmental delay, sibling of a child with autism, premature birth, small for gestational age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD infants</arm_group_label>
    <description>Healthy infants with 9 months of age (+/- 2 weeks)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult pilots and TD infants will be recruited from a community sample. AR infants will be&#xD;
        recruited from local early intervention providers and pediatricians, following procedures&#xD;
        of ongoing collaborative studies at NIH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITIERIA:&#xD;
&#xD;
        Healthy adults&#xD;
&#xD;
          -  Age of 18-65 at study entry&#xD;
&#xD;
          -  Healthy and good condition as determined by medical history and physical examination&#xD;
&#xD;
        Healthy Infants&#xD;
&#xD;
          -  9 months +/- 2 weeks of age at time of consent&#xD;
&#xD;
          -  Healthy and good condition a as determined by medical history and physical examination&#xD;
&#xD;
          -  Age appropriate development as determined by parent report and exam&#xD;
&#xD;
          -  Full term at birth&#xD;
&#xD;
          -  Normal weight for gestational age&#xD;
&#xD;
        At Risk Infants&#xD;
&#xD;
          -  12 months +/- 2 weeks at the time of consent&#xD;
&#xD;
          -  Must have at least one of the following: observed developmental delay; sibling of a&#xD;
             child with autism; premature birth; small for gestational age&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Healthy Adults&#xD;
&#xD;
          -  Uncorrected auditory impairment&#xD;
&#xD;
          -  Uncorrected visual impairment&#xD;
&#xD;
          -  Head injury with loss of consciousness&#xD;
&#xD;
          -  Inability to provide consent&#xD;
&#xD;
          -  Subject has a condition that in the opinion of the investigator creates an&#xD;
             unacceptable risk for participation&#xD;
&#xD;
        Healthy and At-Risk infants&#xD;
&#xD;
          -  Not being exposed to English as the primary language spoken at home&#xD;
&#xD;
          -  Having a medical impairment that interferes with study participation such as having a&#xD;
             g-tube, shunt or seizure disorder and inability to hold one s head upright&#xD;
&#xD;
          -  Having a known visual impairment&#xD;
&#xD;
          -  Having a known auditory impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amir Gandjbakhche, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wan-Chun Su</last_name>
    <phone>(301) 496-6786</phone>
    <email>wan-chun.su@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amir Gandjbakhche, Ph.D.</last_name>
    <phone>(301) 435-9235</phone>
    <email>amir@helix.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Maryland, College Park</name>
      <address>
        <city>College Park</city>
        <state>Maryland</state>
        <zip>20740</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Selin Zeytinoglu, M.D.</last_name>
      <phone>Not Listed</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2018-CH-0001.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Thorpe SG, Cannon EN, Fox NA. Spectral and source structural development of mu and alpha rhythms from infancy through adulthood. Clin Neurophysiol. 2016 Jan;127(1):254-269. doi: 10.1016/j.clinph.2015.03.004. Epub 2015 Mar 20.</citation>
    <PMID>25910852</PMID>
  </reference>
  <reference>
    <citation>Vanderwert RE, Fox NA, Ferrari PF. The mirror mechanism and mu rhythm in social development. Neurosci Lett. 2013 Apr 12;540:15-20. doi: 10.1016/j.neulet.2012.10.006. Epub 2012 Oct 11.</citation>
    <PMID>23063953</PMID>
  </reference>
  <reference>
    <citation>Anderson AA, Smith E, Chowdhry FA, Thurm A, Condy E, Swineford L, Manwaring SS, Amyot F, Matthews D, Gandjbakhche AH. Prefrontal Hemodynamics in Toddlers at Rest: A Pilot Study of Developmental Variability. Front Neurosci. 2017 May 30;11:300. doi: 10.3389/fnins.2017.00300. eCollection 2017.</citation>
    <PMID>28611578</PMID>
  </reference>
  <verification_date>April 17, 2023</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Near Infrared Spectroscopy</keyword>
  <keyword>EEG</keyword>
  <keyword>Functional Brain Activity</keyword>
  <keyword>Neurodevelopment</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodevelopmental Disorders</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/NCT03307317
org study id: 180001
secondary id: 18-CH-0001
nct id: NCT03307317
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      People show changes in brain activity when they watch other people do actions. This may be
      part of early social and communication skills. Researchers want to understand the stages of
      normal development of motor observation and imitation in people and how it relates to social
      development in infants and toddlers.

      Objective:

      To study the nature of brain activity that underlies typical brain functioning in infants,
      toddlers, and adults.

      Eligibility:

      Infants ages 9 12 months

      Healthy adults ages 18 65

      Design:

      Adult participants will have one visit. They will:

      Answer questions about their family, like its size and ethnicity.

      Answer questions about their own behavior and do a simple motor task.

      Have EEG/fNIRS. A damp elastic cap with small sensors will be placed on the head.
      Participants will observe stimuli, either on a video screen or of a live person. The sensors
      will be connected to a computer. That will record the participant s brain activity while
      watching pictures on a screen.

      Infant participants will have 2 visits.

      Their parents will answer questions about their family.

      The parents will fill out forms about their child s development. These will be mailed to them
      before each visit.

      Parents will stay with their infant while study staff does an assessment of the child s
      communication, motor, and thinking skills.

      Infants will have EEG/fNIRS.

      Infants who are at risk for developmental delays will come back for another visit when they
      are about 2 years old. This will repeat the infant visits but it will not include EEG/fNIRS.

      Some questionnaires and assessments will be videotaped.
Objective: This investigation has two main objectives: 1) combine two child-friendly brain
      imaging techniques and stochastic modeling to determine the neural basis for the development
      of imitation and mimicry in human infants and 2) use machine learning to identify brain
      activation patterns that predict impairment in imitation and mimicry in infants at risk for
      social communication disorders.

      Study Population: This study will focus on two groups of infants. The first group includes 60
      typically developing infants, who will complete the imitation and neuroimaging paradigm
      between the ages of 9-12 months (+/- 2 weeks) and again at 12 months of age

      (+/- 2 weeks). The second group includes 60 infants at increased risk for social
      communication disorders, including those with motor delay, language delay, preterm birth, or
      a sibling with an autism spectrum disorder. These infants will complete the imitation and
      neuroimaging paradigm at 12 months of age (+/- 1 month) as well as a follow up evaluation of
      social communication skills and developmental status at 24 months of age (+/- 1 month).

      Design: We propose to conduct longitudinal studies of changes in EEG and fNIRS correlates of
      mirror neuron network activity in typical development and infants at risk for social
      communication delay. We will measure both EEG mu suppression and hemodynamic change over the
      motor cortex during an established infant action/observation paradigm. At all study visits,
      infants will also complete developmental assessments that measure abilities in cognitive,
      motor, language, and social domains.

      Outcome measures: Both neuroimaging measures and developmental status will serve as outcomes
      for this study. For the typically developing infants, change in the neuroimaging metrics
      (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to

      characterize development of the mirror neuron system, while the relation between neuroimaging
      variables, their trajectories, and developmental ability will be used to develop hypotheses
      about the role of the mirror neuron network in development of social communication skills.
      For the infants at risk for social communication disorders, the main outcome will be
      developmental status, with neuroimaging metrics used as predictors.
observational model: Case-Control
time perspective: Prospective
measure: Developmental level
time frame: Visit 2 for AR group
description: Diagnostic status and behavioral scales that reflect child development at different levels: gross motor, fine motor, language and visual reception.
measure: Hemodynamic response function and mu suppression
time frame: Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants
description: The change in neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to characterize the development of the mirror neuron system.
arm group label: Adult pilots
description: Healthy adults between the ages of 18-65 years
arm group label: AR infants
description: Infants with 12 months of age (+/- 2 weeks) with one of the following: observed developmental delay, sibling of a child with autism, premature birth, small for gestational age.
arm group label: TD infants
description: Healthy infants with 9 months of age (+/- 2 weeks)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 9 Months
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amir Gandjbakhche, Ph.D.
role: Principal Investigator
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
last name: Wan-Chun Su
phone: (301) 496-6786
email: wan-chun.su@nih.gov
last name: Amir Gandjbakhche, Ph.D.
phone: (301) 435-9235
email: amir@helix.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2018-CH-0001.html
description: NIH Clinical Center Detailed Web Page
citation: Thorpe SG, Cannon EN, Fox NA. Spectral and source structural development of mu and alpha rhythms from infancy through adulthood. Clin Neurophysiol. 2016 Jan;127(1):254-269. doi: 10.1016/j.clinph.2015.03.004. Epub 2015 Mar 20.
PMID: 25910852
citation: Vanderwert RE, Fox NA, Ferrari PF. The mirror mechanism and mu rhythm in social development. Neurosci Lett. 2013 Apr 12;540:15-20. doi: 10.1016/j.neulet.2012.10.006. Epub 2012 Oct 11.
PMID: 23063953
citation: Anderson AA, Smith E, Chowdhry FA, Thurm A, Condy E, Swineford L, Manwaring SS, Amyot F, Matthews D, Gandjbakhche AH. Prefrontal Hemodynamics in Toddlers at Rest: A Pilot Study of Developmental Variability. Front Neurosci. 2017 May 30;11:300. doi: 10.3389/fnins.2017.00300. eCollection 2017.
PMID: 28611578
responsible party type: Sponsor
mesh term: Neurodevelopmental Disorders