[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100217292":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":10,"locations":20,"responsibleParty":34,"collaborators":36,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"ElMindA Ltd","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Normative study",null,"male and female athletes, ages 8-14.",{"label":13,"type":10,"description":14,"interventionNames":10},"Baseline","male and female athletes, ages 8-18.",[16],{"name":17,"affiliation":18,"role":19},"Gregory Myer, PhD","Children's Hospital Medical Center, Cincinnati","PRINCIPAL_INVESTIGATOR",[21],{"facility":22,"status":10,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":10},"Cincinnati children's hospital Sport center","Cincinnati","Ohio","45229-3039","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-84.51439,39.12711,{"lat":32,"lon":31},{"type":35,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[37],{"name":18,"class":38},"OTHER","100217292","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-100217292",false,"NCT02105935","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","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.","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.",true,"ALL","8 Years","18 Years",{"count":51,"type":52},200,"ACTUAL","OBSERVATIONAL","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.",[56,57],"Normative","Concussed","COMPLETED","2020-07-20",{"date":61,"type":52},"2020-07-22",{"date":63,"type":10},"2014-04",{"date":65,"type":52},"2018-06",{"name":5,"class":6},1]