<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/NCT04469335</url>
  </required_header>
  <id_info>
    <org_study_id>1905-145-1035</org_study_id>
    <nct_id>NCT04469335</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Mobile Neurofeedback for ADHD Youth</brief_title>
  <official_title>Comparative Clinical Trial With Double-blind Randomized Sham Control and Additive Treatment Toward Efficacy of Mobile Neurofeedback for ADHD Youth : An Exploratory Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Childrens Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wonkwang University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Childrens Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective: Verification of ADHD Treatment Effectiveness of Mobile Neurofeedback to Subjects&#xD;
      of Child and Youth with ADHD.&#xD;
&#xD;
      Method: Mobile Neurofeedback Program is implemented for 165 ADHD patients aged 8 to 15 to&#xD;
      verify their effectiveness by conducting pre-post evaluation. Prior to the implementation of&#xD;
      the intervention, we conduct a survey with demographic information, behavioral&#xD;
      characteristics, clinical global impression, neuropsychological test, brain MRI, NIRS and&#xD;
      EEG.&#xD;
&#xD;
      The drug naive subjects are randomly assigned to the mobile Neurofeedback group or Sham&#xD;
      control group. The subjects on medication are randomly assigned to the mobile Neurofeedback&#xD;
      group or Sham control group, In addition to the medication being administered.&#xD;
&#xD;
      The intervention are conducted three times a week, twice a day, and 10-20 minutes for 12&#xD;
      weeks, and the effectiveness is assessed four times in advance, third month, sixth month and&#xD;
      twelfth months.&#xD;
&#xD;
      However, the Sham control group were provided the same machines and programs as the&#xD;
      Neurofeedback exercise, but feedback is generated randomly regardless of ectroencephalogram&#xD;
      change of the subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>2nd week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>4th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>8th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>third month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>sixth month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Korean Attention Deficit Hyperactivity Disorder rating scale</measure>
    <time_frame>twelfth month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>2nd week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>4th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>8th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>third month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>sixth month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression Scale-Severity</measure>
    <time_frame>twelfth month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>2nd week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>4th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>8th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>third month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>sixth month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Global Assessment Scale</measure>
    <time_frame>twelfth month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>brain MRI</measure>
    <time_frame>at the beginning, third month, sixth month, twelfth month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EEG power in beta band</measure>
    <time_frame>at the beginning, third month, sixth month, twelfth month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EEG power in theta band</measure>
    <time_frame>at the beginning, third month, sixth month, twelfth month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near Infra-Red Spectroscopy</measure>
    <time_frame>at the beginning, third month, sixth month, twelfth month</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">165</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>mobile neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>sham control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>medication +mobile neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>medication + sham control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mobile neurofeedback</intervention_name>
    <description>to maximize usability and effectiveness, we would like to conduct a study that regulates theta/beta ratio using mobile app-based Neurofeedback Training Equipment (OmniCNS).&#xD;
The actual Neurofeedback training allows you to download and use the omnifit brain_Game, an application with an audio guide. After the pre-assessment, the researcher will provide guidance to subjects and carers on how to use the application, and demonstrate how to use it in practice. For 2 weeks, 4 weeks and 6 weeks, phone calls are conducted to check whether they are used or not and for any inconvenience. After 12 weeks of Neurofeedback training, the device is returned and post-evaluated.&#xD;
The application is equipped with four types of games and is instructed to use the three-day-a-week application. For Neurofeedback attention and cognitive training, use a headset with left and right frontal lobe 2 channel-EEG sensors to perform the game through feedback to see if it is concentrating well.</description>
    <arm_group_label>mobile neurofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham mobile neurofeedback</intervention_name>
    <description>It uses the sham devices and programs as the Neurofeedback, but it is not usually possible to obtain the expected effects of the Neurofeedback by providing random feedback regardless of actual brain waves.&#xD;
In case of Sham control group, parental education is conducted the same for each clinical evaluation, and in case of Sham control group, actual Neurofeedback is applied if patients and parents want it after the end of the study.</description>
    <arm_group_label>sham control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>medication + mobile neurofeedback</intervention_name>
    <description>The mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.</description>
    <arm_group_label>medication +mobile neurofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>medication + Sham mobile neurofeedback</intervention_name>
    <description>The sham mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.</description>
    <arm_group_label>medication + sham control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient between the ages of 8 and 15&#xD;
&#xD;
               -  Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria and&#xD;
                  K-SADS-PL ③ IQ 80 or higher ④ Neurofeedback or Sham treatment group include&#xD;
                  patients who have not received methylphenidate/atomoxetine medication in the past&#xD;
                  or who have been treated with methylphenidate less than a year and not taken&#xD;
                  methylphenidate/atomoxetine within four weeks of starting point of this study.&#xD;
&#xD;
                    -  medication+Neurofeedback or medication+Sham treatment group include ADHD&#xD;
                       patients undergoing methylphenidate or atomoxetine medication over the past&#xD;
                       month without changes in capacity. And ADHD patients whose CGI-S scale is 4&#xD;
                       or higher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with congenital genetic disease&#xD;
&#xD;
               -  Patients with a clear history of acquired brain damage, such as cerebral palsy. ③&#xD;
                  Patients with convulsions, other neurological disorders, or uncorrected sensory&#xD;
                  disorders&#xD;
&#xD;
                    -  Patients with a history of schizophrenia, other childhood psychosis ⑤ IQ&#xD;
                       below 80 ⑥ Patient with obsessive compulsive disorder, major depression or&#xD;
                       bipolar disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Boong Nyun Kim, MD, PhD</last_name>
    <phone>+82-10-3637-1558</phone>
    <email>kbn1@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Childrens' Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boong Nyun Kim, MD, PhD</last_name>
      <phone>+82-10-3637-1558</phone>
      <email>kbn1@snu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Boong Nyun Kim, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Inhyhang Kim, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chan-Mo Yang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hyung Seo Park, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Minsup Shin, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gahye Noh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Narae Yoon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Childrens Hospital</investigator_affiliation>
    <investigator_full_name>Booog Nyung Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT04469335
org study id: 1905-145-1035
nct id: NCT04469335
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: Verification of ADHD Treatment Effectiveness of Mobile Neurofeedback to Subjects
      of Child and Youth with ADHD.

      Method: Mobile Neurofeedback Program is implemented for 165 ADHD patients aged 8 to 15 to
      verify their effectiveness by conducting pre-post evaluation. Prior to the implementation of
      the intervention, we conduct a survey with demographic information, behavioral
      characteristics, clinical global impression, neuropsychological test, brain MRI, NIRS and
      EEG.

      The drug naive subjects are randomly assigned to the mobile Neurofeedback group or Sham
      control group. The subjects on medication are randomly assigned to the mobile Neurofeedback
      group or Sham control group, In addition to the medication being administered.

      The intervention are conducted three times a week, twice a day, and 10-20 minutes for 12
      weeks, and the effectiveness is assessed four times in advance, third month, sixth month and
      twelfth months.

      However, the Sham control group were provided the same machines and programs as the
      Neurofeedback exercise, but feedback is generated randomly regardless of ectroencephalogram
      change of the subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: baseline
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: 2nd week
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: 4th week
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: 8th week
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: third month
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: sixth month
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
time frame: twelfth month
measure: Clinical Global Impression Scale-Severity
time frame: baseline
measure: Clinical Global Impression Scale-Severity
time frame: 2nd week
measure: Clinical Global Impression Scale-Severity
time frame: 4th week
measure: Clinical Global Impression Scale-Severity
time frame: 8th week
measure: Clinical Global Impression Scale-Severity
time frame: third month
measure: Clinical Global Impression Scale-Severity
time frame: sixth month
measure: Clinical Global Impression Scale-Severity
time frame: twelfth month
measure: Children's Global Assessment Scale
time frame: baseline
measure: Children's Global Assessment Scale
time frame: 2nd week
measure: Children's Global Assessment Scale
time frame: 4th week
measure: Children's Global Assessment Scale
time frame: 8th week
measure: Children's Global Assessment Scale
time frame: third month
measure: Children's Global Assessment Scale
time frame: sixth month
measure: Children's Global Assessment Scale
time frame: twelfth month
measure: brain MRI
time frame: at the beginning, third month, sixth month, twelfth month
measure: EEG power in beta band
time frame: at the beginning, third month, sixth month, twelfth month
measure: EEG power in theta band
time frame: at the beginning, third month, sixth month, twelfth month
measure: Near Infra-Red Spectroscopy
time frame: at the beginning, third month, sixth month, twelfth month
arm group label: mobile neurofeedback
arm group type: Experimental
arm group label: sham control
arm group type: Sham Comparator
arm group label: medication +mobile neurofeedback
arm group type: Experimental
arm group label: medication + sham control
arm group type: Sham Comparator
intervention type: Device
intervention name: mobile neurofeedback
description: to maximize usability and effectiveness, we would like to conduct a study that regulates theta/beta ratio using mobile app-based Neurofeedback Training Equipment (OmniCNS).
The actual Neurofeedback training allows you to download and use the omnifit brain_Game, an application with an audio guide. After the pre-assessment, the researcher will provide guidance to subjects and carers on how to use the application, and demonstrate how to use it in practice. For 2 weeks, 4 weeks and 6 weeks, phone calls are conducted to check whether they are used or not and for any inconvenience. After 12 weeks of Neurofeedback training, the device is returned and post-evaluated.
The application is equipped with four types of games and is instructed to use the three-day-a-week application. For Neurofeedback attention and cognitive training, use a headset with left and right frontal lobe 2 channel-EEG sensors to perform the game through feedback to see if it is concentrating well.
arm group label: mobile neurofeedback
intervention type: Device
intervention name: Sham mobile neurofeedback
description: It uses the sham devices and programs as the Neurofeedback, but it is not usually possible to obtain the expected effects of the Neurofeedback by providing random feedback regardless of actual brain waves.
In case of Sham control group, parental education is conducted the same for each clinical evaluation, and in case of Sham control group, actual Neurofeedback is applied if patients and parents want it after the end of the study.
arm group label: sham control
intervention type: Device
intervention name: medication + mobile neurofeedback
description: The mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.
arm group label: medication +mobile neurofeedback
intervention type: Device
intervention name: medication + Sham mobile neurofeedback
description: The sham mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.
arm group label: medication + sham control
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: No
last name: Boong Nyun Kim, MD, PhD
phone: +82-10-3637-1558
email: kbn1@snu.ac.kr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Childrens Hospital
investigator full name: Booog Nyung Kim
investigator title: Professor
mesh term: Attention Deficit Disorder with Hyperactivity