Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-28 @ 10:21 PM
Study NCT ID:
NCT02105935
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.', 'timeFrame': '1 year', 'description': 'quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Normative', 'Concussed']}, 'descriptionModule': {'briefSummary': "This study's objectives are:\n\n* To prospectively examine changes in brain network activation (BNA™) from baseline to recovery (i.e., return to activity) in youth and adolescent athletes with concussion.\n* To assess the clinical utility of changes in BNA to assist in clinical decision-making.\n* To generate normative BNA data.", 'detailedDescription': 'Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. 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 proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male and female athletes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2).\n\n * For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and currently symptomatic\n * Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.\n * Willingness to participate and able to give informed assent (child) and Parental consent\n\nExclusion Criteria:\n\n* Currently with lice or open wounds on scalp.\n* Long and thick hair that prevents the proper administration of an EEG cap.\n* Significant sensory deficits, e.g., deafness or blindness.\n\n * Normative Exclusion Criteria:\n* Any chronic disease as determined by clinical evaluation and medical history.\n* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)\n* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation\n* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation\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* History of any clinically significant brain trauma as determined by the investigator.'}, 'identificationModule': {'nctId': 'NCT02105935', 'briefTitle': 'Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes', 'organization': {'class': 'INDUSTRY', 'fullName': 'ElMindA Ltd'}, 'officialTitle': 'Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes.', 'orgStudyIdInfo': {'id': 'ELM-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normative study', 'description': 'male and female athletes, ages 8-14.'}, {'label': 'Baseline', 'description': 'male and female athletes, ages 8-18.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati children's hospital Sport center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Gregory Myer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ElMindA Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}