[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"concussion-mild\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:concussion-mild":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,48,75,102,131,161,197,221,248,281,304],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100579100","acceptance-and-commitment-therapy-integrated-vestibular-rehabilitation-active-rct-100579100",false,"NCT06819904","Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT","Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial","Inclusion Criteria:\n\n* 18-49 years of age\n* Normal\u002Fcorrected vision\n* Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional.\n* mTBI-related symptoms and\u002For impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache\u002Fmigraine, ocular, or sleep. as determined by self-report.\n\nExclusion Criteria:\n\n* History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report.\n* History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.\n* Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.\n* Previous moderate to severe TBI as determined by self-report.\n* \\\u003C 8 days following current mTBI as determined by self-report.\n* Currently pregnant as determined by self-report.","ALL","18 Years","49 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.",[27,28,29],"Concussion, Mild","Mild Traumatic Brain Injury (mTBI)","Psychological Health",[31,32,33,34],"concussion","mTBI","psychological health","treatment","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-02-27",{"date":43,"type":21},"2027-08",{"name":45,"class":46},"University of Pittsburgh","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100610092","use-of-tinted-contact-lenses-for-concussion-related-light-sensitivity-100610092","NCT07223086","Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity","Inclusion Criteria:\n\n* diagnosed mild traumatic brain injury (concussion)\n* age 18 or older\n* Within 24 months of initial injury\n* experiencing symptoms of photophobia (light sensitivity), increased photophobia since the injury, or no symptoms of photophobia\n\nExclusion Criteria:\n\n* moderate or severe concussion\n* active infection or inflammation that contradicts the use of soft contact lenses\n* subjects unable to safely perform insertion and removal of the contact lenses",{"count":55,"type":21},60,[24],"The purpose of this study is to gather pilot data on the effectiveness of daily disposable tinted contact lenses in reducing photophobia (light sensitivity) following a concussion, with the goal of facilitating the return to work or school.",[27,59,60],"Photophobia","Contact Lens",[62,63,64],"Mild concussion","tinted contact lenses","light sensitivity","2026-06-10",{"date":67,"type":39},"2026-06-11",{"date":69,"type":39},"2026-05-08",{"date":71,"type":21},"2027-04-01",{"name":73,"class":46},"University of Alabama at Birmingham",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100587556","pro-2-cool-pivotal-trial-ii-100587556","NCT06929923","Pro-2-Cool Pivotal Trial II","A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population","Inclusion Criteria:\n\n1. Males and females, 13-21 years of age\n2. Confirmed concussion diagnosis consistent with American Congress Rehabilitation Medicine guidelines 21, without any of the following:\n\n   * Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury\n   * Loss of consciousness greater than 30 minutes\n   * Post-traumatic amnesia lasting over 24 hours\n3. Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.\n4. Post-Concussion Symptom Scale Score minimum of 15\n5. Initial provider visit is within 7 days of injury\n6. In generally good health as confirmed by medical history and determined by site investigator or designated trained healthcare professional under the supervision of the principal investigator.\n7. Has informed consent obtained per protocol and as required per Institutional Review Board\n\nExclusion Criteria:\n\n1. Age \\\u003C 13 years or \\> 21 years\n2. Inability to understand the study requirements or provide informed consent\n3. Cleared to return to play during initial visit\n4. Prior participation in a Pro2Cool Clinical Study\n5. Serious traumatic brain injury as evidenced by worsening symptoms:\n\n   * Vomiting \\> 2 episodes following injury\n   * Seizure\n   * Hospitalization\n   * Radiology scan indicating brain bleed\n   * Slurred speech which has not resolved within 72 hours of concussive injury\n6. Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms\n7. Hemodynamic instability\u002Fmedical condition requiring further acute life-saving medical intervention\n8. History of psychiatric disorder that includes suicide attempts within the last 6 months, unmanaged depression or anxiety, hospitalization for psychiatric treatment within the last 6 months\n9. Known brain mass, intracranial hemorrhage, skull fracture\n10. Scalp abnormalities including laceration or bleeding\n11. Presence of ventriculoperitoneal (VP) shunt\n12. Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma\n13. Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and\u002For a history of severe migraines\n14. Known or disclosed pregnancy or breast-feeding\n15. Sustains another head or neck injury at the time of concussive injury which requires medical treatment","13 Years","21 Years",{"count":85,"type":21},66,[24],"This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.",[27],[90,91],"Non-invasive hypothermic therapy","Sports-related concussion","2026-06-09",{"date":67,"type":39},{"date":95,"type":39},"2025-02-20",{"date":97,"type":21},"2027-06",{"name":99,"class":100},"TecTraum Inc.","INDUSTRY",3,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":17,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":74},"100496221","facilitating-access-to-specialty-treatment-100496221","NCT05741411","Facilitating Access to Specialty Treatment","Utilizing Mobile Health to Expedite Access to Specialty Care for Youth Presenting to the Emergency Department With Concussion at Highest Risk of Developing Persisting Symptoms","Inclusion Criteria for concussed subjects:\n\n* Males and females age 13 - 18\n* Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury\n* Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion\n* Own a smartphone\n* Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score \\>3\u002F12)\n\nExclusion Criteria for concussed subjects:\n\n* Glasgow Coma Scale score \\\u003C13\n* Lower extremity trauma\n* A prior concussion within 1 month\n* Non-English speaking\n* Admission to the hospital at the initial head injury visit\n* Previously enrolled in the study\n* Inability to complete study procedures.\n\nInclusion Criteria for parents:\n\n* Child meets the study eligibility criteria\n\nExclusion Criteria for parents:\n\n* Non-English speaking\n\nInclusion Criteria for providers:\n\n* ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy\n\nExclusion Criteria for providers:\n\n* Non-English speaking",{"count":110,"type":21},210,[24],"The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.",[114,27,115,116],"Mild Traumatic Brain Injury","Concussion, Severe","Concussion, Intermediate",[118,119,120,121],"mobile health","emergency department","persistent post-concussion symptoms","remote patient monitoring","2026-05-20",{"date":124,"type":39},"2026-05-22",{"date":126,"type":39},"2024-03-11",{"date":128,"type":21},"2027-08-01",{"name":130,"class":46},"Children's Hospital of Philadelphia",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":74},"100524220","eye-recovery-automation-for-post-injury-dysfunction-irapid-100524220","NCT06105892","Eye Recovery Automation for Post Injury Dysfunction (iRAPID)","Eye Recovery Automation for Post Injury Dysfunction","iRAPID","Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria:\n\n1. are aged 18 - 40;\n2. have suffered a mTBI according to VA\u002FDepartment of Defense (DoD) criteria with documented evidence of alteration of consciousness (AOC) \\\u003C 24 hours or loss of consciousness (LOC) less than 30 minutes;\n3. were injured between 1 month and 15 years ago;\n4. received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;\n5. experienced less than 24 hours of post-traumatic amnesia (PTA), if any;\n6. have ongoing post-concussive symptoms as evidenced by a score of 18 or greater or a score of 2 or greater on question 6 (vision problems, blurring, trouble seeing) on the Neurobehavioral Symptom Inventory (NSI);\n7. have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);\n8. have PTCI as evidenced by obtaining a score of 21 or higher on the convergence insufficiency symptom survey (CISS), a specific measure of convergence insufficiency;\n9. are fluent in English; and\n10. have been on stable doses of any vision-altering medications for the past 2 months.\n11. Stereopsis of 500 sec arc using Randot Stereo Test.\n12. Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance\n13. Near point of convergence (NPC) \\> 5 cm\n14. Convergence amplitude at near \\\u003C 15PD break or the Sheard criterion not met\n\nControl Inclusion Criteria:\n\n1. are aged 18 - 40;\n2. CISS score of 20 or lower;\n3. near point of convergence (NPC) \\\u003C 6cm; and\n4. positive fusional range \\>15 prism diopters.\n5. Stereopsis of 500 sec arc using Randot Stereo Test.\n\nExclusion Criteria:\n\n1. prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;\n2. history of psychosis, as there are known visual performance findings associated with psychosis;\n3. history of current or recent (within two years) substance\u002Falcohol dependence, to reduce confounding effects on visual function\n4. recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;\n5. any condition that would prevent the participant from completing the protocol;\n6. appointment of a legal representative, to avoid coercion of a vulnerable population;\n7. any ongoing litigation related to TBI, to prevent interference with legal proceedings;\n8. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.\n9. Previous vergence therapy, orthoptics, home-based therapy, etc.\n10. Amblyopia or constant strabismus or strabismus surgery.\n11. High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia \\>1.5PD difference between eyes; Prior refractive surgery.\n12. Manifest or latent nystagmus evident clinically.\n13. Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).",true,"40 Years",{"count":142,"type":21},100,[24],"This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.",[146,147,27],"Convergence Insufficiency","Traumatic Brain Injury",[149,150,151,146,147],"Virtual Reality","Cross-Sectional","Therapy","2026-04-09",{"date":154,"type":39},"2026-04-14",{"date":156,"type":39},"2023-10-23",{"date":158,"type":21},"2027-09-20",{"name":160,"class":46},"New Jersey Institute of Technology",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":169,"maxAge":17,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":178,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100613926","mindfulness-based-intervention-for-pediatric-mild-traumatic-brain-injury-100613926","NCT07272941","Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury","Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)","MBI-4-mTBI","Inclusion Criteria:\n\n* Participants presenting to five PERC EDs after sustaining a direct or indirect head injury\n* Aged 12 through 17.99 years\n* Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition\n* Score ≥6 on the 5P rule\n* Suffered the index injury in the previous 48 hours\n* Proficient in English or French\n\nExclusion Criteria:\n\n* Glasgow Coma Scale ≤13\n* Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)\n* Neurosurgical operative intervention, intubation or intensive care required\n* Multi-system injuries with treatment requiring hospital admission, operating room or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)\n* Severe neurological developmental delay resulting in communication difficulties\n* Intellectual disability\u002Fmental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)\n* Intoxication at the time of ED presentation as per clinician judgment\n* No clear history of trauma as primary events (e.g., seizure, syncope or migraine)\n* Prior psychiatric hospitalization\n* Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)\n* Inability to obtain a proper written informed consent\u002Fassent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)\n* Legal guardian not present (certain forms need be completed by parents\u002Flegal guardians)\n* No internet or mobile\u002Ftablet access.\n* Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.","12 Years",{"count":171,"type":21},362,[24],"Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.",[175,176,177],"Concussions","Mild Traumatic Brain Injury, Concussion","Concussion Mild",[179,180,31,181,182,183,34,184,185],"mild traumatic brain injury","mtbi","intervention","meditation","quality of life","Persistent post-concussive symptoms","mindfulness","NOT_YET_RECRUITING","2026-03-17",{"date":189,"type":39},"2026-03-18",{"date":191,"type":21},"2026-05",{"date":193,"type":21},"2029-12",{"name":195,"class":46},"Children's Hospital of Eastern Ontario",5,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":74},"100504494","concussion-treatment-in-older-adults-100504494","NCT05849064","Concussion Treatment in Older Adults","Randomized Controlled Trial of Targeted Treatment in Older Adults Following Concussion","Inclusion Criteria:\n\n* 50 years of age or older\n* Diagnosed concussion within the last 4 days - 12 months\n* Must be recruited at their initial concussion appointment\n* Ability to read\u002Fwrite to complete study assessments\u002Ftesting\n\nExclusion Criteria:\n\n* Diagnosed major psychiatric disorders other than depression\u002Fanxiety (e.g., schizophrenia)\n* Diagnosed with moderate to severe brain injury or past brain surgery\u002Fmalformations","50 Years","99 Years",{"count":207,"type":21},50,[24],"The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.",[27],[31,179,34,212],"older adults","2026-03-03",{"date":215,"type":39},"2026-03-05",{"date":217,"type":39},"2023-09-07",{"date":219,"type":21},"2026-07",{"name":45,"class":46},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":232,"phases":4,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":74},"100484443","rapid-accurate-cost-effective-assessment-of-blood-biomarkers-for-diagnosis-of-concussion-100484443","NCT05588115","Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion","RACE Study: Rapid, Accurate and Cost-effective Analysis of Glial Fibrillary Acid Protein Using a Hand-held Biosensor for Patient With Concussion in Acute Care and at Home Monitoring","RACE","Inclusion Criteria (concussion group):\n\n1. diagnosed with an uncomplicated concussion according to the ICD-10 criteria with no intracranial abnormalities\n2. between the ages of 18-65 years old.\n\nInclusion Criteria (MSK group):\n\n1. diagnosed with any form of musculoskeletal injury in absence of comorbidities\n2. between the ages of 18-65 years old\n\nExclusion Criteria:\n\n1. complicated mild TBI (positive neuroimaging findings)\n2. current or history of moderate or severe traumatic brain injury\n3. history of neurological issue(s) (stroke, seizures, dementia, Alzheimer's, etc.) or metabolic disease(s) (diabetes, liver disease, kidney disease, cardiovascular disease, etc.)\n4. greater than 7 days from injury at initial visit","65 Years",{"count":231,"type":21},225,"OBSERVATIONAL","The goal of this observational study is to test if a biosensor can accurately measure a blood biomarker in adult patients presenting to the emergency department with concussion. The main questions it aims to answer are:\n\n* Does the biosensor measure the blood biomarker of interest with the same accuracy as the current gold-standard assay technique?\n* Do relationships exist between blood biomarker measurements from the biosensor and any psychological or physical symptoms of concussion?\n\nParticipants will be asked to provide blood samples at initial visit and 2-, 6-, and 12-weeks after injury while completing questionnaires at each visit, along with a brief (2 min) daily symptom inventory.\n\nResearchers will compare the concussion group to a muscle\u002Fskeletal injury group to see if measurements from the biosensor are exclusive to concussion.",[27],[236,237,238,31],"blood biomarkers","GFAP","biosensor","2026-02-02",{"date":241,"type":39},"2026-02-05",{"date":243,"type":39},"2022-12-01",{"date":245,"type":21},"2027-12",{"name":247,"class":46},"University of Calgary",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":255,"minAge":17,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":74},"100616309","female-concussion-head-cooling-100616309","NCT07303933","Female Concussion Head Cooling","The Association Between Head Cooling and Cognition, Neuroinflammatory Cytokines, Menstrual Cycle, Sleep Patterns, Mental Health and Concussions","Inclusion Criteria:\n\n1. Require that any participant is 18-27 years old\n2. Require that participants be English speakers\n3. Require that participants are females\n4. Require that persons be able to provide consent for themselves\n\nExclusion Criteria:\n\n1. Exclude persons under 18 years old or over 27 years old\n2. Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1\n3. Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)\n4. Those with scalp infections, sun burns, skin cancers, and\u002For prior surgical scars should not participate\n5. Those with presence of an active infection (including a dental infection)\n6. Exclude persons who have migraines\n7. Exclude persons taking mood stabilizer medications\n8. Exclude persons who have consumed alcohol within 48 hours prior to study participation.\n9. Exclude persons who are males","FEMALE","27 Years",{"count":258,"type":21},32,[24],"This research is being done to examine the benefits of a 28 day head cooling intervention on cognition, inflammation of the brain, sleep quality, menstrual symptom interaction, and mood in acutely concussed females. Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for decreasing timeline of full concussion recovery, particularly in females during periods of confounding neuropsychological menstrual symptoms, remains unexplored.",[262,263,27],"Concussion (Diagnosis)","Concussion Post Syndrome",[265,266,267,268,269,270,271],"Brain cooling","Concussion","Neuroinflammation","Mental Health","Cognition","Menstrual cycle","Female","2025-12-23",{"date":274,"type":39},"2025-12-26",{"date":276,"type":21},"2026-01-15",{"date":278,"type":21},"2027-01-01",{"name":280,"class":46},"Penn State University",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":232,"phases":4,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100578776","interdisciplinary-interventions-after-mtbi-100578776","NCT06815692","Interdisciplinary Interventions After mTBI","Effect of Interdisciplinary Interventions After Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* Adults who are medically diagnosed with a concussion.\n* Adults with a connection to the labor market.\n* Participants must be able to communicate in Danish and be able to independently participate in the intervention.\n* Participants must be able to transport themsleves to and from SuB facility for their treatment sessions.\n* Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score must be at least 20, indicating a significant severity of symptoms following a concussion.\n\nExclusion Criteria:\n\n* Persons without medically verified concussion.\n* Person where brain injury was found at symptom onset.\n* Persons with significant cognitive dysfunction.\n* Persons who are unable to understand Danish or with communication disorders that hinder test performance.\n* Persons with terminal illness or other progressive disease.\n* Chronic use of opioids.\n* Significant abuse of alcohol or euphoriants or narcotics or other serious illnesses that may affect test results or ability\u002Fpossibility of attendance.",{"count":289,"type":21},140,"The investigators aim to investigate the impact of interdisciplinary and individually tailored programs for mTBI (concussion) on quality of life and work capacity, both at the conclusion of the program and after 1 and 3 years. The investigators also want to examine whether early intervention is significant by comparing individuals who enter the program between 1 and 3 months post-concussion with those who only start the program more than 9 months post-concussion. Such a study has not been conducted before and can provide valuable insights into long-term effects and the importance of early intervention",[27],[32,293,294,183,266],"employment","weekly working hours","2025-08-11",{"date":297,"type":39},"2025-08-12",{"date":299,"type":21},"2026-01-01",{"date":301,"type":21},"2030-12-31",{"name":303,"class":46},"Rune Skovgaard Rasmussen",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":312,"maxAge":17,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":74},"100559110","impact-of-a-paced-breathing-exercise-intervention-on-autonomic-nervous-system-function-after-pediatric-concussion-100559110","NCT06559865","Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion","Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study","Breathe","Inclusion Criteria:\n\n* aged 9-18 years\n* seven days-3 months post-concussion,\n* at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances).\n\nExclusion Criteria:\n\n* known heart disease,\n* previous neurological problems other than concussion","9 Years",{"count":314,"type":21},20,[24],"The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention.\n\nParticipants will:\n\nwill be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program.\n\nA weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments.\n\nAll participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.",[27],"2024-09-27",{"date":320,"type":39},"2024-10-01",{"date":322,"type":39},"2024-06-01",{"date":324,"type":21},"2024-12-15",{"name":326,"class":46},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre"]