[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-concussion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-concussion":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,50,83,110,138,178,207,234,262,290,314],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054323","rehabilitation-education-and-self-management-for-adolescents-after-mild-traumatic-brain-injury-100054323",false,"NCT07698015","Rehabilitation, Education, and SElf-management for Adolescents After Mild Traumatic Brain Injury","A Decentralized, Investigator Blinded, Randomized, Parallel-group Study to Determine the Feasibility of an 8-week Smart-phone App Delivered Mindfulness- Based Intervention Versus a Health Education Program for Adolescents With Persisting Symptoms After Concussion\u002FmTBI","RESET","Inclusion Criteria:\n\n1. Age 12-18\n2. Structured interview confirming a concussion\u002FmTBI or suspected concussion\u002FmTBI diagnosis according to the American Congress of Rehabilitation Medicine definition\n3. Concussion\u002FmTBI occurred 1-12 months prior to randomization\n4. Persisting symptoms after concussion as demonstrated by a score \\>75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group\n5. English proficiency\n\nExclusion Criteria:\n\n1. Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis)\n2. Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., \\\u003C2 weeks post-injury).","ALL","12 Years","18 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.",[28,29,30],"Brain Concussion","Mild Traumatic Brain Injury","Concussion",[32,33,34,35,36],"concussion","mild traumatic brain injury","mindfulness-based intervention","digital health","persisting symptoms after concussion","NOT_YET_RECRUITING","2026-07-06",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":22},"2026-09-01",{"date":45,"type":22},"2028-05-31",{"name":47,"class":48},"Molly Cairncross","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":49},"100497865","neuromodulation-and-neuroimaging-in-older-children-with-mild-traumatic-brain-injury-100497865","NCT05762796","Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury","Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury","CI-tDCS","Experimental Cohort:\n\nInclusion Criteria:\n\n* age 10-15 years at enrollment\n* enrolled after 6 weeks of mTBI injury\n* exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)\n* Sustained an mTBI or concussion within the past 12 months\n* Parent and child proficient in English\n\nHealthy Controls Cohort:\n\nInclusion Criteria:\n\n* 10 to 15 years old\n* no concussion history\n* Parent and child proficient in English\n\nExperimental Cohort:\n\nExclusion Criteria:\n\n* loss of consciousness \\> 30 minutes\n* post-traumatic amnesia \\> 24 hours\n* intracranial findings on clinical imaging\n* history of developmental delay\n* history of learning disability or ADHD\n* Sustained a lower limb or upper limb injury that has not healed\n* History of Seizures\n* Noticeable skin lesions\u002Fburns or any other severe skin problems at the site of the electrodes before the start of the stimulation.\n* Parent\u002Fguardian report metal implants anywhere in the head\u002Fncek\u002Fbody on the MRI screening form (see attached).\n* Parent\u002Fguardian report shrapnel\u002Fbullets in the body on the MRI screening form.\n* Parent\u002Fguardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.\n* Parent\u002Fguardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.\n* Parent\u002Fguardian report being claustrophobic on the MRI screening form.\n* Parent\u002Fguardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.\n* Pregnant females as reported by parent\u002Fguardian on the pre-consent screening form. Pubertal\u002Fpost-pubertal female participants14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.\n\nHealthy Controls Cohort:\n\nExclusion Criteria:\n\n* diagnosed with developmental delay\n* sustained a lower limb or upper limb injury that has not healed\n* history of Learning Disability and\u002For ADHD\n* Parent\u002Fguardian report metal implants anywhere in the head\u002Fncek\u002Fbody on the MRI screening form (see attached).\n* Parent\u002Fguardian report shrapnel\u002Fbullets in the body on the MRI screening form.\n* Parent\u002Fguardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.\n* Parent\u002Fguardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.\n* Parent\u002Fguardian report being claustrophobic on the MRI screening form.\n* Parent\u002Fguardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.\n* Pregnant females as reported by parent\u002Fguardian on the pre-consent screening form. Post-pubertal females 14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.",true,"10 Years","15 Years",{"count":62,"type":22},10,[25],"Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.",[28,29,66,67],"Motor Disorders","Cognitive Impairment",[28,29,69,70,67,71,72],"Child","Motor Activity","Transcranial Direct Current Stimulation","Neuroimaging","RECRUITING","2026-02-02",{"date":76,"type":41},"2026-02-03",{"date":78,"type":41},"2024-02-20",{"date":80,"type":22},"2027-06",{"name":82,"class":48},"State University of New York at Buffalo",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":58,"sex":17,"minAge":19,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100477520","exercise-reset-for-concussion-in-a-military-environment-100477520","NCT05498038","Exercise Reset for Concussion in a Military Environment","Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment","Inclusion Criteria (Participants):\n\nFor the CSM Group:\n\n* Active-duty service member\n* Aged 18-40 years\n* Injury occurred within 9 days of injury\n* Diagnosed with concussion by an experienced clinician using standard international criteria\n\nFor the HC Group:\n\n* Active-duty service member\n* Ages 18-40\n\nExclusion Criteria (Participants):\n\nFor the CSM group:\n\n* Moderate or severe TBI as indicated by a GCS score \\\u003C13, lesion on CT\u002FMRI, and\u002For focal neurologic sign consistent with intracerebral lesion\n* Injury involving loss of consciousness for \\>30 minutes or post-traumatic amnesia \\>24 hours\n* Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk\n* Pre-existing conditions that prevent participation in active testing and\u002For rehabilitation\n* Active substance abuse\u002Fdependence\n* Unwillingness to perform intervention\n* Limited English proficiency\n* Confirmed pregnancy\n\nFor the HC group:\n\n* Has lingering symptoms from a previous concussion or has recovered from a concussion less than 1-month ago\n* On a limited profile or \"chit\" for light duty\n* Active substance abuse\u002Fdependence\n* Unwilling to perform intervention\n* Limited English proficiency\n* Confirmed pregnancy\n\nInclusion Criteria (Providers):\n\n* Active duty\n* Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis\n* Willing to participate\n* Able to be contacted by telephone or Zoom\n\nExclusion Criteria (Providers):\n\n* Not active duty\n* Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management\n* Only involved in concussion management at emergent timepoint\n* Unwilling to participate\n* Unable to be contacted by telephone or Zoom","40 Years",{"count":92,"type":22},168,[25],"Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery. We will conduct a prospective four-year multicenter mechanistic treatment (Phase 3) RCT in CSM of personalized sub-threshold aerobic exercise added to the PRA compared with the PRA alone. Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise.",[28],[32,97,98,99,100],"military","aerobic exercise","recovery","return to duty","2026-01-16",{"date":103,"type":41},"2026-01-21",{"date":105,"type":41},"2024-08-07",{"date":107,"type":22},"2026-09-30",{"name":82,"class":48},2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":109},"100600461","concussion-recovery-and-support-program-100600461","NCT07097792","Concussion Recovery and Support Program","Pilot Study of Concussion Recovery and Support Program (CRISP)","CRISP","Inclusion Criteria:\n\n* Diagnosed with a concussion and at least 2 weeks from injury but less than two years.\n* New or worsening headache since concussion\n* Had at least one day with headache last week of moderate severity or two days with headache of any severity\n\nExclusion Criteria:\n\n* Non-English speaking\n* Chronic medical illness\u002F medical complexity\n* Housing instability\n* Acute mental health issues such as active suicidality, psychiatric hospitalization within the past 6 months, ER visit for suicidality in the past 6 months or experiencing psychosis or delusions","29 Years",{"count":120,"type":22},40,[25],"Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-29 yo with concussion\u002F mild TBI.",[28,29,124],"Headache",[126,127,128],"mental health","therapy","emotional awareness and expression therapy","2025-11-14",{"date":131,"type":41},"2025-11-18",{"date":133,"type":41},"2025-10-13",{"date":135,"type":22},"2026-07-31",{"name":137,"class":48},"Seattle Children's Hospital",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":161,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":109},"100547838","remotely-supervised-tdcs-for-complex-attention-in-mtbi-cognetric-100547838","NCT06413173","Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)","Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI (Cognetric)","COGNETRIC","Inclusion Criteria:\n\n1. Active-Duty Service Members.\n2. Ages 18 to 60.\n3. All genders.\n4. All racial and ethnic groups.\n5. History of mild TBI (as defined by the DOD\u002FVA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.\n6. Self-reported attention and\u002For concentration difficulties.\n7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.\n\nExclusion Criteria:\n\n1. Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of: brain tumor, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania.\n2. History of prior treatment with ECT or neuromodulation in the last 12 months.\n3. Current, diagnosed substance dependence.\n4. Newly prescribed medication within the previous 3 weeks.\n5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).\n6. Any medical condition or treatment other than mild TBI (e.g., stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgment, would impact risk.\n7. Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and\u002For a review of available medical records\n8. Contraindications for tDCS (e.g., metallic cranial plates\u002Fscrews or implanted device, eczema or skin lesions on scalp)\n9. A positive pregnancy report.","60 Years",{"count":148,"type":22},160,[25],"The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called \"Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training\" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.",[28,152,153,154,155,156,157,158,29,159,160],"Brain Trauma","Attention Concentration Difficulty","Brain Injuries","Brain Injuries, Traumatic","Neurocognitive Dysfunction","Attention Impaired","Memory Impairment","Mild Cognitive Impairment","Post Concussive Symptoms",[162,163,164,165,166,167],"Military Health","Brain Stimulation","Cognitive Training","Cognitive Rehabilitation","Telehealth","Neuromodulation","2025-11-07",{"date":170,"type":41},"2025-11-12",{"date":172,"type":41},"2024-07-25",{"date":174,"type":22},"2028-09-30",{"name":176,"class":177},"United States Naval Medical Center, San Diego","FED",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":58,"sex":17,"minAge":19,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":49},"100524696","phase-1-repetitive-transcranial-magnetic-stimulation-for-post-concussion-headaches-100524696","NCT06112093","Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches","Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study","Inclusion Criteria:\n\n* 18 - 55 years old\n* mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours\n* diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria\n* headache develops within 7 days after head trauma\n* headache persists for \\>=3 months after head trauma despite receiving standard care\n* average persistent headache intensity is \\>= 3\u002F10 of the numerical rating scale (NRS) on \\>=3days\u002Fweek\n* no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation\n* no evidence of other possible causes of headaches\n\nExclusion Criteria:\n\n* history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI\n* history of other neurologic conditions with medications affecting the central nervous system\n* contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip","55 Years",{"count":187,"type":22},60,[189],"PHASE1","This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.",[28,29,124,192],"Post-Concussion Symptoms",[194,195,167,196,197],"Repetitive transcranial magnetic stimulation","Non-invasive brain stimulation","Chronic pain","Biomarkers","2025-10-08",{"date":200,"type":41},"2025-10-10",{"date":202,"type":41},"2023-10-23",{"date":204,"type":22},"2027-10-23",{"name":206,"class":48},"State University of New York - Upstate Medical University",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":49},"100503624","problem-solving-training-for-concussion-100503624","NCT05837676","Problem-Solving Training for Concussion","Problem-Solving Training for Concussion (PST-Concussion): A Brief, Skills-Focused Intervention to Improve Functional Outcomes in Veterans With mTBI and Co-occurring Mental Health Symptoms","PST-Concussion","Inclusion Criteria:\n\n* English-speaking Veteran enrolled in VHA care;\n* History of concussion (mild traumatic brain injury or mTBI);\n* Current psychological distress;\n* Subjective neurocognitive symptoms of \\>= 3 months.\n\nExclusion Criteria:\n\n* Moderate to severe TBI or other major neurocognitive disorder;\n* Psychotic disorder (e.g., schizophrenia spectrum disorder, delusional disorder, bipolar or depressive disorder with psychotic features);\n* Acute suicidal ideation;\n* Inpatient psychiatric hospitalization within the past 12 months;\n* Other illness\u002F condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team.",{"count":216,"type":22},134,[25],"Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.",[28],[29,221,222,223,224],"Concussion, Mild","Veterans","Neurobehavioral Manifestations","Psychological Distress","2025-09-04",{"date":227,"type":41},"2025-09-08",{"date":229,"type":41},"2023-10-01",{"date":231,"type":22},"2027-09-30",{"name":233,"class":177},"VA Office of Research and Development",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":260,"locationsCount":49},"100517277","exercise-in-postconcussion-symptoms-and-posttraumatic-headache-100517277","NCT06015451","Exercise in Postconcussion Symptoms and Posttraumatic Headache","Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.","Inclusion Criteria:\n\n* Age 18-65 years\n* Having sustained a minimal head injury or mild traumatic brain injury at least 2 weeks ago.\n* At least one postconcussion symptoms, of at least moderate degree, occurring within the first week after the head injury.\n* Intolerance for physical activity (self-reported and measured; including symptom exacerbation later on the test day).\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n* More than 2 years since last injury.\n* The symptoms are better explained by other conditions.\n* Severe communication problems, typically due to poor knowledge of Norwegian.\n* Severe psychiatric, neurological, somatic, or substance abuse disorders that will make it problematic to function in a group and\u002For will complicate follow-up and outcome assessment.\n* Safety concerns according to the study medical checklist.","65 Years",{"count":243,"type":22},100,[25],"The goal of this clinical trial is to compare two models of delivery of guided exercise in patients with exercise intolerance after mild head injury.\n\nThe main question it aims to answer is:\n\n• Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a program with telephone-based follow-up only?\n\nParticipants will undergo a treadmill test to determine eligibility for the study, and to determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to be the symptom threshold. One group will receive face-to-face folllow-up and repeated testing, one group will receive telephone-based follow-up only .\n\nResearchers will compare these two groups to see if closer follow-up is superior when it comes to recovery from exercise intolerance after 12 weeks of exercise.",[28,247,248,249],"Post-Concussion Syndrome","Post-Traumatic Headache","Craniocerebral Trauma",[251,252,253],"exercise intolerance","exercise","Thread mill test","2025-07-07",{"date":256,"type":41},"2025-07-08",{"date":258,"type":41},"2022-11-01",{"date":43,"type":22},{"name":261,"class":48},"St. Olavs Hospital",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":146,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":49},"100457198","get-going-after-concussionn-lite-100457198","NCT05233475","Get Going After concussIonN Lite","Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults","GAIN Lite","Inclusion Criteria:\n\n1. Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;\n2. Age 18 to 60 years at the time of the trauma;\n3. A total score of 10-30 on RPQ within 1 week before enrolment in the study;\n4. Able to understand, speak and read Danish;\n5. Living in Central Denmark Region;\n6. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion\n\nExclusion Criteria:\n\n1. Objective neurological findings and\u002For acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;\n2. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion\n3. Severe misuse of alcohol, prescription drugs and\u002For illegal drugs\n4. Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.",{"count":243,"type":22},[25],"Background:\n\nConcussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative.\n\nAims:\n\n1. To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: \"Get going After concussion Lite\" (GAIN Lite).\n2. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.\n\nMethods:\n\nA randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.",[28,29,274],"Commotio Cerebri",[276,277,278,279,280,281],"Brain concussion","Behavior therapy","Early intervention","Mild traumatic brain injury","Post-concussion syndrome","Rivermead post-concussion symptoms questionaire","2025-03-28",{"date":284,"type":41},"2025-04-02",{"date":286,"type":41},"2023-02-13",{"date":231,"type":22},{"name":289,"class":48},"University of Aarhus",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":241,"enrollmentInfo":297,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":49},"100475679","erp-changes-pre-and-post-military-changes-100475679","NCT05474066","ERP Changes Pre and Post Military Changes","Pilot Trial Examining the Impact of Training Related Sub-Concussive Forces On Cognition and Selected Electroencephalogram Measures In Canadian Special Forces Members","Inclusion Criteria:\n\n* ● Male or female between 18 and 65\n\n  * Normal or corrected to normal vision and hearing (Note: If the patient has hearing aids or wears glasses, they are still able to complete the assessment. They will need to remove hearing aids for the Attention \\& Concentration and Information Processing test)\n  * Sit still for 10-15 minutes\n  * Understand basic instructions of cognitive tests\n\nExclusion Criteria:\n\n* ● Metal plates under their scalp that cross the midline\n\n  * Taking epilepsy medications\n  * History of neurologic or neuropsychiatric disorder prior to concussion in controls\n  * Taking psychotropic medications\n  * History of complete deafness\n  * Supplements or performance enhancing drugs that can affect brain function",{"count":298,"type":22},20,"OBSERVATIONAL","This study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.",[28],[303,304,97],"erp","eeg","2024-02-10",{"date":307,"type":41},"2024-02-13",{"date":309,"type":41},"2022-08-01",{"date":311,"type":22},"2026-12-01",{"name":313,"class":48},"Canadian Forces Health Services Centre Ottawa",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":58,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":4},"100526169","the-s100-levels-in-patients-with-mild-brain-injury-100526169","NCT06131242","The s100β Levels in Patients With Mild Brain Injury.","The Application Value of Serum S100β in Acute Mild Traumatic Brain Injury.","Inclusion Criteria:\n\n1. Study on healthy people: Apparently healthy people \\>18 years old who came to our hospital for physical examination.\n2. Study of emergency trauma patients: 1) Emergency trauma patients at least 18 years old with suspected brain injury; 2) Glasgow Coma Score 13-15 (patients with mild traumatic brain injury); 3) Closed head trauma; 4) Clinical judgment of patients requiring craniocerebral CT examination.\n\nExclusion Criteria:\n\n1. Healthy population study: stroke history, trauma, surgery, mental illness, senile dementia, cognitive impairment, and tumor patients within 3 months.\n2. Study of emergency trauma patients: 1) neurological or psychiatric history, 2) intellectual disabilities, 3) alcohol or drug addiction (trauma after drinking was eligible for inclusion, but alcohol consumption was recorded), 4) brain tumor patients, 5) time of trauma was not available, and 6) patients whose clinical conditions were deemed unsuitable for participation in the trial.",{"count":322,"type":22},494,"Mild traumatic brain injury (TBI) accounts for the majority of TBI. At present, whether TBI has traumatic intracranial lession is mainly diagnosed by computed tomography (CT), while only 5% of mild TBI has positive CT results. The risk stratification method for patients with mild TBI is needed to reduce unnecessary CT use and reduce medical costs.\n\nS100β is a protein in glial cells and can be used as a biomarker of brain injury. S100β is showed to have the clinical and economic value in ruling out traumatic intracranial lesions in mild TBI patients in Europe and the United States. However, it was showed to have difference between races, and there lacks systematic research data from Chinese population. In addition, if it is used for emergency departments, it is necessary to evaluate new rapid detection methods.\n\nThis study is based on a novel fast S100β test. The reference intervals of S100β in Chinese adults will be established. Further, evaluation of S100β in diagnosis of traumatic intracranial lesions in acute mild TBI will be conducted from the perspective of clinical and economic value in China, which will provide data for screening of low-risk TBI patients and avoiding unnecessary CT use in clinical practice.",[28],"2023-11-14",{"date":327,"type":41},"2023-11-18",{"date":329,"type":22},"2023-11-09",{"date":331,"type":22},"2026-08-31",{"name":333,"class":48},"Sumei Lu"]