Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-28 @ 6:27 AM
Study NCT ID:
NCT04469335
Status:
UNKNOWN
Last Update Posted:
2020-07-14
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Mobile Neurofeedback for ADHD Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': 'baseline'}, {'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': '2nd week'}, {'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': '4th week'}, {'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': '8th week'}, {'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': 'third month'}, {'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': 'sixth month'}, {'measure': 'Korean Attention Deficit Hyperactivity Disorder rating scale', 'timeFrame': 'twelfth month'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': 'baseline'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': '2nd week'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': '4th week'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': '8th week'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': 'third month'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': 'sixth month'}, {'measure': 'Clinical Global Impression Scale-Severity', 'timeFrame': 'twelfth month'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': 'baseline'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': '2nd week'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': '4th week'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': '8th week'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': 'third month'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': 'sixth month'}, {'measure': "Children's Global Assessment Scale", 'timeFrame': 'twelfth month'}], 'secondaryOutcomes': [{'measure': 'brain MRI', 'timeFrame': 'at the beginning, third month, sixth month, twelfth month'}, {'measure': 'EEG power in beta band', 'timeFrame': 'at the beginning, third month, sixth month, twelfth month'}, {'measure': 'EEG power in theta band', 'timeFrame': 'at the beginning, third month, sixth month, twelfth month'}, {'measure': 'Near Infra-Red Spectroscopy', 'timeFrame': 'at the beginning, third month, sixth month, twelfth month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'Objective: Verification of ADHD Treatment Effectiveness of Mobile Neurofeedback to Subjects of Child and Youth with ADHD.\n\nMethod: 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.\n\nThe 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.\n\nThe 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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient between the ages of 8 and 15\n\n * Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria and K-SADS-PL ③ IQ 80 or higher ④ Neurofeedback or Sham treatment group include patients who have not received methylphenidate/atomoxetine medication in the past or who have been treated with methylphenidate less than a year and not taken methylphenidate/atomoxetine within four weeks of starting point of this study.\n\n * medication+Neurofeedback or medication+Sham treatment group include ADHD patients undergoing methylphenidate or atomoxetine medication over the past month without changes in capacity. And ADHD patients whose CGI-S scale is 4 or higher.\n\nExclusion Criteria:\n\n* Patients diagnosed with congenital genetic disease\n\n * Patients with a clear history of acquired brain damage, such as cerebral palsy. ③ Patients with convulsions, other neurological disorders, or uncorrected sensory disorders\n\n * Patients with a history of schizophrenia, other childhood psychosis ⑤ IQ below 80 ⑥ Patient with obsessive compulsive disorder, major depression or bipolar disorder'}, 'identificationModule': {'nctId': 'NCT04469335', 'briefTitle': 'Effectiveness of a Mobile Neurofeedback for ADHD Youth', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Childrens Hospital'}, 'officialTitle': 'Comparative Clinical Trial With Double-blind Randomized Sham Control and Additive Treatment Toward Efficacy of Mobile Neurofeedback for ADHD Youth : An Exploratory Study.', 'orgStudyIdInfo': {'id': '1905-145-1035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mobile neurofeedback', 'interventionNames': ['Device: mobile neurofeedback']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham control', 'interventionNames': ['Device: Sham mobile neurofeedback']}, {'type': 'EXPERIMENTAL', 'label': 'medication +mobile neurofeedback', 'interventionNames': ['Device: medication + mobile neurofeedback']}, {'type': 'SHAM_COMPARATOR', 'label': 'medication + sham control', 'interventionNames': ['Device: medication + Sham mobile neurofeedback']}], 'interventions': [{'name': 'mobile neurofeedback', 'type': 'DEVICE', '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).\n\nThe 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.\n\nThe 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.', 'armGroupLabels': ['mobile neurofeedback']}, {'name': 'Sham mobile neurofeedback', 'type': 'DEVICE', '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.\n\nIn 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.', 'armGroupLabels': ['sham control']}, {'name': 'medication + mobile neurofeedback', 'type': 'DEVICE', '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.', 'armGroupLabels': ['medication +mobile neurofeedback']}, {'name': 'medication + Sham mobile neurofeedback', 'type': 'DEVICE', '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.', 'armGroupLabels': ['medication + sham control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Boong Nyun Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kbn1@snu.ac.kr', 'phone': '+82-10-3637-1558'}, {'name': 'Boong Nyun Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Inhyhang Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chan-Mo Yang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyung Seo Park, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Minsup Shin, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gahye Noh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Narae Yoon, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Seoul National University Childrens' Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Boong Nyun Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kbn1@snu.ac.kr', 'phone': '+82-10-3637-1558'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Childrens Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanyang University', 'class': 'OTHER'}, {'name': 'Wonkwang University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Booog Nyung Kim', 'investigatorAffiliation': 'Seoul National University Childrens Hospital'}}}}