Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04221620
Status:
UNKNOWN
Last Update Posted:
2020-01-09
First Post:
2019-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004569', 'term': 'Electroencephalography'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Co-PI Catherine Young will be completing all evaluations and de-indentification of study participants. I (Lauren Hall) will be working with the de-identified data.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One single group of 30 pediatric participants will undergo 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback within each session. Standardized assessment will be administered at the beginning of the session and at the end of 20 sessions to compare differences between executive functioning skills.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Executive functioning improvements', 'timeFrame': 'minimum 20 weeks, up to 8 months', 'description': 'Executive functioning improvements as indicated by improved scores on the Behavior Rating Inventory of Executive Functioning second edition, or BRIEF-2, at the end of 20 sessions when EEG neurofeedback was utilized. The BRIEF-2 is considered the gold standard for testing executive functioning and has over 1000 peer reviewed articles. It utilizes three different scoring sub-sections- typical, potentially clinically elevated. or clinically elevated. Participants in this study must score within the potentially clinically elevated or clinically elevated levels to qualify. Ideally, moving up one section to typical range or potentially elevated range would demonstrate positive study results.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['EEG neurofeedback', 'occupational therapy'], 'conditions': ['Executive Functioning', 'Pediatric ALL']}, 'descriptionModule': {'briefSummary': 'EEG Neurofeedback is a noninvasive way that allows the central nervous system to self regulate and the frontal cortex to be accessed through quieting of the limbic system at the subcortical level. Currently there is limited research in regards to the implications of EEG Neurofeedback, however, the investigators of this study have been using EEG Neurofeedback as a passive modality in the treatment of various pediatric clients with a variety of diagnoses and disorders. The purpose of this study is to determine whether or not EEG neurofeedback is effective in improving executive functioning skills in pediatric, school aged children as a modality in traditional occupational therapy services. The investigators hypothesize that EEG neurofeedback will assist with improved sensory gating abilities, therefore allowing for higher levels of cognition and awareness due to increased opportunities for the brain to regulate itself.', 'detailedDescription': "Electroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. There is limited research in regards to the use of EEG Neurofeedback, however, occupational therapists Cat Young and Lauren Hall have been using EEG Neurofeedback alongside traditional therapy as 'background noise' with pediatric clients. These therapists have observed children experience steady increases in speech and language abilities, self-care tasks such as becoming potty trained, and better abilities to understand self-regulation of emotions with EEG Neurofeedback when used together with traditional occupational therapy services. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head.\n\nThe purpose of this study is to test the effectiveness of EEG Neurofeedback in improving executive functioning skills in pediatric school aged children. The investigators hypothesize is that the EEG Neurofeedback will allow the body to filter out unnecessary information and white noise to focus on the task at hand, and therefore access higher levels of cognition and awareness by helping the brain to regulate itself. This study does not require additional time outside of the therapy session. Some of these clients already received treatment in therapy. The purpose of this consent form is to use the data gained from the client's BRIEF-2 scores and therapy sessions to test effectiveness of this device.\n\nFurthermore, the purpose of the study is to determine potential benefits of using EEG Neurofeedback alongside traditional occupational therapy in improving executive functioning skills in school aged children. Requirements include children who experience impairments based on scores of potentially clinically elevated or clinically elevated levels on the Behavior Rating Inventory of Executive Function 2, or the BRIEF-2. This assessment is considered the gold standard for testing executive functioning and has over 1000 peer reviewed articles. At time of evaluation, the parent(s) or legal caregiver(s) will be given one (1) BRIEF-2 parental rating scale, which will take an average of 10-15 minutes to complete. Each question will be answered via a three point scale for whether they see the specific behavior often, sometimes, or never. Potential benefits include improved ability to stay on task, organize and complete tasks. There is minimal risk associated with the use of EEG Neurofeedback. Children might experience discomfort with the sensors placed on their head and attached to their ears. Some children might initially feel uncomfortable with the experience of being a relaxed alert state if they are prone to being in heightened alert states."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* school aged children: ages 6 to 18 years old.\n* score of 4 out of 9 on the BRIEF-2 assessment, indicating a potentially clinically elevated or clinically elevated need for therapeutic intervention\n\nExclusion Criteria:\n\n* score of 3 or less of the 9 categories on the BRIEF\n* ratings that are equal to or higher than 7 on the inconsistency scale (indicating parent/caregiver bias)\n* age requirements not met'}, 'identificationModule': {'nctId': 'NCT04221620', 'briefTitle': 'Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning', 'organization': {'class': 'OTHER', 'fullName': 'Northern Arizona University'}, 'officialTitle': 'Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning', 'orgStudyIdInfo': {'id': 'northernAU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EEG neurofeedback', 'description': 'All participants will receive 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback.', 'interventionNames': ['Device: Zengar Electroencephalogram (EEG) Neurofeedback device']}], 'interventions': [{'name': 'Zengar Electroencephalogram (EEG) Neurofeedback device', 'type': 'DEVICE', 'description': 'Electroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head while receiving traditional occupational therapy services.', 'armGroupLabels': ['EEG neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86305', 'city': 'Prescott', 'state': 'Arizona', 'country': 'United States', 'contacts': [{'name': 'Lauren Hall, OTD', 'role': 'CONTACT', 'email': 'laurenhallotd@gmail.com', 'phone': '623-606-0883'}, {'name': 'Catherine Young, MOT', 'role': 'CONTACT', 'email': 'catherine_young_@gmail.com', 'phone': '9286428747'}], 'facility': 'Kidabilities Occupational Therapy', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}], 'centralContacts': [{'name': 'Lauren Hall, OTD', 'role': 'CONTACT', 'email': 'LaurenHallOTD@gmail.com', 'phone': '6236060883'}, {'name': 'Catherine Young, MOT', 'role': 'CONTACT', 'email': 'Catherine_young_@gmail.com', 'phone': '9286428747'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Currently no plans to make individual participant data available. If plans change, all information will be de-identifiable and unable to be traced to specific participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Arizona University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kidabilities Occupational Therapy Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Occupational Therapy', 'investigatorFullName': 'Lauren Hall', 'investigatorAffiliation': 'Northern Arizona University'}}}}