xml: <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/NCT06006637</url>
    </required_header>
    <id_info>
      <org_study_id>2041726</org_study_id>
      <secondary_id>111111</secondary_id>
      <nct_id>NCT06006637</nct_id>
    </id_info>
    <brief_title>Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder</brief_title>
    <acronym>IPMR ASD</acronym>
    <official_title>Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>State University of New York - Upstate Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>JelikaLite LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>State University of New York - Upstate Medical University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY&#xD;
        Upstate Medical University with 40 autistic children evaluating the effects of transcranial&#xD;
        photobiomodulation (tPBM) on multiple clinically validated scales.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed intervention will noninvasively deliver near infra-red (NIR) light -&#xD;
        transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is&#xD;
        delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The&#xD;
        Cognilum system is a non-invasive headband medical device specifically designed to safely and&#xD;
        comfortably deliver tPBM to autistic children. Cognilum has been designated as a&#xD;
        non-significant risk breakthrough device by the Food and Drug Administration. This study will&#xD;
        consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical&#xD;
        University with 40 autistic children using Cognilium device and measuring the impact using&#xD;
        multiple clinically validated scales.&#xD;
  &#xD;
        Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before&#xD;
        and after treatment comparison) in the active group compared to sham-control group.&#xD;
  &#xD;
        Hypothesis 2: Significant change in average scores (before and after treatment comparison) on&#xD;
        the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I)&#xD;
        scale in the active group compared to sham control group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>All participants and their caregivers will be held blind to group assignment. The PI will also remain blind to participant group assignment and conduct the pre- and post-assessment batteries (i.e., CARS-2, SRS, and CGI-I). Two clinical research assistants and co-investigator, will randomly assign participants to groups and have knowledge of their assignment. A third research assistant will also be held blind to group assignment and complete weekly interviews with caregivers.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Childhood Autism Rating Scale, Second edition</measure>
      <time_frame>10 weeks</time_frame>
      <description>Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Social Responsiveness Scale, Second Edition</measure>
      <time_frame>10 weeks</time_frame>
      <description>Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorder.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Global Impressions Scale</measure>
      <time_frame>10 weeks</time_frame>
      <description>A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>CognilumTM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>During the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cognilum TM: Light Treatment Condition</intervention_name>
      <description>The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.</description>
      <arm_group_label>CognilumTM</arm_group_label>
      <arm_group_label>Sham control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 2 - 8&#xD;
  &#xD;
            -  Autism spectrum disorder diagnosis&#xD;
  &#xD;
            -  CARS-2 score of 30 - 45&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  CARS scores less than 30 or over 45.&#xD;
  &#xD;
            -  Taking medications on a regular basis&#xD;
  &#xD;
            -  Having skin lesions on scalp&#xD;
  &#xD;
            -  Having history of seizures&#xD;
  &#xD;
            -  Having history of abnormal EEG&#xD;
  &#xD;
            -  Being a relative of the PI or a researcher&#xD;
  &#xD;
            -  Having implanted devices (including cochlear implants).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>William E Sullivan, PhD</last_name>
      <phone>315-464-3932</phone>
      <email>sullivaw@upstate.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Henry S Roane, PhD</last_name>
      <phone>315-464-3555</phone>
      <email>roaneh@upstate.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Transcranial photobiomodulation</keyword>
    <keyword>Autism Spectrum Disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No individual participant data (IPD) will be available to other researchers</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006637
  org study id: 2041726
  secondary id: 111111
  nct id: NCT06006637
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY
        Upstate Medical University with 40 autistic children evaluating the effects of transcranial
        photobiomodulation (tPBM) on multiple clinically validated scales.
  The proposed intervention will noninvasively deliver near infra-red (NIR) light -
        transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is
        delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The
        Cognilum system is a non-invasive headband medical device specifically designed to safely and
        comfortably deliver tPBM to autistic children. Cognilum has been designated as a
        non-significant risk breakthrough device by the Food and Drug Administration. This study will
        consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical
        University with 40 autistic children using Cognilium device and measuring the impact using
        multiple clinically validated scales.
  
        Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before
        and after treatment comparison) in the active group compared to sham-control group.
  
        Hypothesis 2: Significant change in average scores (before and after treatment comparison) on
        the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I)
        scale in the active group compared to sham control group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: All participants and their caregivers will be held blind to group assignment. The PI will also remain blind to participant group assignment and conduct the pre- and post-assessment batteries (i.e., CARS-2, SRS, and CGI-I). Two clinical research assistants and co-investigator, will randomly assign participants to groups and have knowledge of their assignment. A third research assistant will also be held blind to group assignment and complete weekly interviews with caregivers.
  measure: Childhood Autism Rating Scale, Second edition
  time frame: 10 weeks
  description: Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation.
  measure: Social Responsiveness Scale, Second Edition
  time frame: 10 weeks
  description: Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorder.
  measure: Clinical Global Impressions Scale
  time frame: 10 weeks
  description: A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention.
  arm group label: CognilumTM
  arm group type: Experimental
  description: During the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.
  arm group label: Sham control
  arm group type: Sham Comparator
  description: During the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.
  intervention type: Device
  intervention name: Cognilum TM: Light Treatment Condition
  description: The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.
  arm group label: CognilumTM
  arm group label: Sham control
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 8 Years
  healthy volunteers: No
  last name: William E Sullivan, PhD
  phone: 315-464-3932
  email: sullivaw@upstate.edu
  last name: Henry S Roane, PhD
  phone: 315-464-3555
  email: roaneh@upstate.edu
  responsible party type: Sponsor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: No
  ipd description: No individual participant data (IPD) will be available to other researchers