[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-brain-injury-with-loss-of-consciousness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-brain-injury-with-loss-of-consciousness":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100553034","cerebral-autoregulation-brain-perfusion-and-neurocognitive-outcomes-after-traumatic-brain-injury-100553034",false,"NCT06480838","Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury","CAPCOG-TBI","Inclusion Criteria:\n\n* Documented\u002FVerified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV pedestrian\u002Fcyclist, fall, other non-intentional, violence\u002Fassault)\n* A documented moderate to severe TBI defined as: Glasgow Coma Scale (GCS) \\\u003C 13, or loss of consciousness (LOC) \\> 30 minutes, or posttraumatic amnesia (PTA) \\> 24 hours or intracranial neuroimaging abnormalities\n* Between the age 18 - 80 year-old\n* ≤ 1 week postinjury\n* Acute brain CT for clinical care\n* Admitted to the hospital for TBI\n* Visual acuity\u002Fhearing adequate for testing\n* Fluent in English or Spanish\n* Patient or LAR ability to provide informed consent\n\nExclusion Criteria:\n\n* Age greater or less than the range 18-80 years\n* Significant polytrauma that would interfere with follow-up and outcome assessment\n* Major debilitating baseline mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression with active suicidal thoughts at the time of evaluation) that would interfere with follow-up and the validity of outcome assessment.\n* Major debilitating neurological disease (e.g., stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.\n* Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g., active substance abuse, alcoholism, HIV\u002FAIDs, end-stage cancers, learning disabilities, developmental disorders)\n* Patients on psychiatric hold\n* Prisoners or patients in custody\n* Pregnancy in female subjects\n* Low likelihood of follow-up (e.g., participants or family indicating low interest, residence in another state or country, homeless or lack of reliable contacts)\n* Current participant in an interventional trial (e.g., drug, device, behavioral)\n* Penetrating TBI\n* Spinal cord injury with ASIA score of C or worse\n* Contraindications to MRI","ALL","18 Years","80 Years",{"count":20,"type":21},130,"ESTIMATED","OBSERVATIONAL","Cognitive impairment after moderate to severe traumatic brain injury (msTBI) not only significantly affects the quality of life in individuals with msTBI, but also increases the possibility of late-life dementia. The goal of this study is to determine whether acute (\\\u003C 1 week) cerebrovascular injury and its recovery within the first year postinjury measured by cerebral autoregulation and brain perfusion are associated with cognitive outcome at 12 months after msTBI. The results from this study will improve our understanding of cerebrovascular contributions to cognitive decline related to TBI and provide critical data to inform the development of strategies based on vascular mechanisms to improve cognition and prevent neurodegeneration after msTBI.",[25,26,27,28,29],"Traumatic Brain Injury With Loss of Consciousness","Brain Injury Traumatic Severe","Brain Injury Traumatic Moderate","TBI (Traumatic Brain Injury)","TBI","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2023-09-01",{"date":38,"type":21},"2029-05-31",{"name":40,"class":41},"University of Texas Southwestern Medical Center","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100528673","phase-2-mesenchymal-stromal-cells-for-traumatic-brain-injury-100528673","NCT06163833","Mesenchymal Stromal Cells for Traumatic Brain Injury","MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury","MATRIx","Inclusion Criteria:\n\n* Age: 18-70 years\n* Clinical frailty index (CFI) \\\u003C 5\n* Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Marshall's CT Classification \\>1)\n* Feasibility of study drug (MSC\u002Fplacebo) administration within 48 hours from TBI\n* GCS ≤ 8 at recruitment and at least one pupil reactive to light\n* ICP monitoring already inserted or planned for clinical indications\n* Weight \\\u003C 100 Kg and \\> 40 kg\n\nExclusion Criteria:\n\n* Motor GCS \\> 5 at recruitment\n* High likelihood (\\> 85%) of death in the first 48 h calculated by IMPACT calculator on early admission data\n* Bilateral mydriasis\n* Opening ICP \\> 40 mmHg\n* Known history of prior brain injury, psychiatric disorder, neurological impairment and\u002For deficit\n* Brain penetrating injury\n* Spinal cord injury\n* Previous epilepsy requiring anti-convulsant therapy\n* Severe organ failure (including PaO2\u002FFiO2\\\u003C200 and shock)\n* Recent serious infectious process\n* Cancer\n* Immunosuppression\n* Human immunodeficiency virus\n* Positive urine pregnancy test or nursing\n* Known risk\u002Fhistory of coagulopathy and thromboembolism\n* Pre-existing and severe:\n\n  * lung disease (such as asthma, chronic obstructive pulmonary disease),\n  * heart dysfunction (as heart failure and reduced cardiac output),\n  * liver insufficiency (as cirrhosis)\n  * kidney insufficiency\n  * and other organ severe abnormalities\n* Known hypersensitivity to excipients used in the formulation (Dimethyl sulfoxide (DMSO), Citrate-dextrose solution (ACD))\n* Participation in a concurrent interventional study","70 Years",{"count":53,"type":21},78,"INTERVENTIONAL",[56],"PHASE2","Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI.\n\nAim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10\\^6 MSCs vs 160 x 10\\^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal damage.\n\nSecondary objectives are aimed to assess:\n\n1. brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days and 14 days post-TBI and at 6 months)\n2. brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation (daily for 3 days after TBI, at day 7 and 14, and at 1, 6 and 12 months)\n3. clinical outcome by a structured clinical and neuropsychological assessment at both 6 and 12 months\n\nMethods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study.\n\nDuration of the study: 36 months (24 of enrolment and 12 of follow up).\n\nFunding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call \"Unmet medical needs\", proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).",[25],[60,61,62,63,64,65],"mesenchimal stromal cells","neuroprotection","neurogenesis","cell therapy","synaptic plasticity","inflammation","2023-12-01",{"date":68,"type":34},"2023-12-11",{"date":70,"type":34},"2023-09-19",{"date":72,"type":21},"2026-12",{"name":74,"class":41},"Fondazione IRCCS San Gerardo dei Tintori"]