[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06901310":3,"trial-entities:NCT06901310":78,"trial-summary:NCT06901310":81},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":61,"locations":64,"central_contacts":74,"overall_officials":75,"references":76,"see_also_links":77},"NCT06901310","HAR10123","A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury","Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury","ENROLLING_BY_INVITATION","2026-12-31","2025-05","2025-08-13","2025-08-07","Michael Harl","OTHER",false,"The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).",null,[19,20,21],"Mild Traumatic Brain Injury (mTBI)","Brain Injury","Concussion",[23,24,25],"brain injury","concussion","Mild traumatic brain injury (mTBI)","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},10,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Hyberbaric Oxygen Therapy","Treating participants with 100% Oxygen at 2.4 Atmospheres for 90 minutes at 10 treatments.",[39],"HBOT Treatment Group",[41],{"measure":42,"description":43,"timeFrame":44},"Impact Neurological Scores","The Impact scores are a percentile 1% to 100%. Any score under 50% is considered a need for neurological or primary care consultation for a concussion","13 Weeks",[],"MALE","18 Years",true,{"inclusion":50,"exclusion":56,"raw_text":60},[51,52,53,54,55],"18 Years or older","Male Unarmed Combat Athlete","30-day suspension (head injury without technical knockout or incapacitation)","60-day suspension (head injury with technical knockout or incapacitation)","90-day suspension (head injury with loss of consciousness)",[57,58,59],"Prisoner status","Female","Suspension group injury severity would not include moderate to severe GCS \\\u003C13","Inclusion Criteria:\n\n* 18 Years or older\n* Male Unarmed Combat Athlete\n* 30-day suspension (head injury without technical knockout or incapacitation)\n* 60-day suspension (head injury with technical knockout or incapacitation)\n* 90-day suspension (head injury with loss of consciousness)\n\nExclusion Criteria:\n\n* Prisoner status\n* Female\n* Suspension group injury severity would not include moderate to severe GCS \\\u003C13\n\nThese suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. This group will be divided into randomized groups, patients who will be treated with HBOT and patients who will receive the standard of care, which is rest.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Marshfield Clinic","Marshfield","Wisconsin","54449","United States",{"lat":72,"lon":73},44.66885,-90.1718,[],[],[],[],{"nct_id":4,"conditions":79,"biomarkers":80},[21],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]