Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 6:06 AM
Study NCT ID:
NCT01460394
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2011-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Data of Brain Network Activation in Adolescents and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2011-10-16', 'studyFirstSubmitQcDate': '2011-10-25', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data', 'timeFrame': '1 week', 'description': 'The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'Control'], 'conditions': ['Healthy Controls']}, 'descriptionModule': {'briefSummary': "Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults.", 'detailedDescription': 'Currently, there is no reliable, practical, and non-invasive method for assessing changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.\n\nThe need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Experimental subjects will include males and females recruited from the Kansas City metropolitan area, Vince \\& Associates Clinical Research's database and from referrals.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 15-24 years.\n* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).\n\nExclusion Criteria:\n\n* Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).\n* Currently with lice, open wounds on scalp.\n* Any chronic disease.\n* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc.\n* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc.\n* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.\n* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.\n* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.\n* Substance abuse in the last 3 months.\n* Significant sensory deficits, e.g., deafness or blindness.\n* History of any brain trauma.'}, 'identificationModule': {'nctId': 'NCT01460394', 'briefTitle': 'Normative Data of Brain Network Activation in Adolescents and Young Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'ElMindA Ltd'}, 'officialTitle': 'Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults', 'orgStudyIdInfo': {'id': 'ELM-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adolescents and young adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Bradley D. Vince, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vince and Associates Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ElMindA Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}