[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-traumatic-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-traumatic-brain-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100372025","contributions-of-mtbi-to-neurodegeneration-due-to-chronic-traumatic-encephalopathy-cte-and-alzheimers-disease-ad-100372025",false,"NCT04124029","Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)","Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease","Inclusion Criteria:\n\nAll Subjects:\n\n* Intact color vision\n* Visual acuity of 20\u002F30 (or better)\n* Patients must pass effort measures on the TOMM\n* Patients must have intact decision-making capacity\n* Patients must have no contraindications to lumbar puncture including:\n* Being on a blood thinner\n* Aspirin or Plavix\n* Have no space occupying lesion on magnetic resonance imaging (MRI)\n* An International Normalized Ratio (INR) value \\\u003C 1.4 and platelet count \\>50,000\n* No epidural infection or overlying cellulitis over the lumbar spine\n* PTSD will be accounted for as a potential confounder and its presence will be included as a covariate in all analyses\n\nMild TBI Subjects:\n\n* Subjects will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis\n* Mild TBI: Loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and\u002For altered mental status greater than 24 hours\n\nModerate TBI Subjects:\n\n* Subjects will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes\n* Moderate TBI: loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours\n\nMCI Subjects:\n\n* Subjects will be recruited that meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria\n* Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function, i.e. will not meet diagnostic criteria for dementia\n* Subjects with MCI may or may not meet diagnostic criteria for MCI due to AD\n* MCI subjects will be matched for their MoCA score with older TBI subjects\n\nHealthy Controls:\n\n* Cognitively normal control subjects, age-, education- and sex-matched with mild TBI subjects, but lacking and TBI history\n* All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled\n\nThe investigators will recruit all subjects without regard to gender, race, ethnicity, socioeconomic status, or other factors to allow results of this research to yield the greatest generalizability\n\nExclusion Criteria:\n\nAll Subjects:\n\n* If the primary language is not English\n* Are unable to understand the informed consent process\n* Have a clinically significant problem with any of the following conditions:\n* A history of TBI within 1 year of study\n* Suicidal or homicidal ideation requiring intervention\n* Schizophrenia\n* Bipolar disorder\n* Active alcohol or drug abuse\n* Clinically significant neurological disease other than those stated in the inclusion criteria\n* Impaired decision-making ability\n* Patients will be excluded if there are contraindications to MRI including:\n* Implants\n* Shrapnel\n* Aneurysm clips\n* Pacemaker\n* Pregnancy\n* Non-TBI subjects must not have had an TBI\n* No contraindication to lumbar puncture or blood draw including:\n* Being on a blood thinner\n* Aspirin or Plavix\n* No space occupying lesion on MRI that makes lumbar puncture contraindicated",true,"ALL","30 Years","90 Years",{"count":21,"type":22},800,"ESTIMATED","OBSERVATIONAL","This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.",[26,27,28],"Mild Traumatic Brain Injury","Moderate Traumatic Brain Injury","Mild Cognitive Impairment",[26,27,30,31,32],"Alzheimer's Disease","Chronic Traumatic Encephalopathy","Neurodegeneration","RECRUITING","2025-09-25",{"date":36,"type":37},"2025-09-26","ACTUAL",{"date":39,"type":37},"2021-07-01",{"date":41,"type":22},"2026-06-30",{"name":43,"class":44},"VA Office of Research and Development","FED",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":45},"100559149","incidence-characteristics-and-evolution-of-cerebral-vasospasm-with-clinical-impact-in-moderate-to-severe-traumatic-brain-injury-complicated-by-subarachnoid-hemorrhage-at-martinique-university-hospital-100559149","NCT06560372","Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital","VASO-TC","Inclusion Criteria:\n\n* Adult patient aged 18 or over,\n* Hospitalized at the Martinique University Hospital for the treatment or monitoring of a moderate or severe TBI (Glasgow Score less than or equal to 13 at initial treatment) presenting with SAH on the cerebral CT scan,\n* Patient if capable, or representative of the patient in case of incapacity, having been informed of the research, and having given free, informed and written consent,\n* After an emergency inclusion procedure if the patient's representative is initially unreachable and written agreement, informed within the first 48 hours of inclusion by the representative or the patient if his neurological condition allows it,\n* Be affiliated to a social security system.\n\nExclusion Criteria:\n\n* Pregnant woman,\n* Presence of an aneurysmal pathology known or diagnosed at initial treatment,\n* History of chronic kidney failure stage 4 (creatinine clearance measured less than 30ml\u002Fmin),\n* Imminent death of the patient,\n* Patient presenting criteria for non-admission to critical care (death expected within 48 hours, progressive fatal pathology with vital prognosis in less than 30 days, patient in palliative situation),\n* Known allergy to iodized contrast products,\n* Be placed under legal protection, guardianship or curatorship,\n* Patient or representative who refused to allow the patient to participate in the study.\n\nAdditional Exclusion Criteria after patient's inclusion:\n\n* Death of the patient expected within the first 48 hours,\n* Minor,\n* Release from hospitalization against medical advice,\n* Transfer to another establishment before the 13th day of treatment (outside the Martinique University Hospital),\n* Change of opinion of the patient's representative (after neurological recovery) regarding the patient's participation in research,\n* Withdrawal of consent to participate in the study being supported with refusal to use the data collected until withdrawal of participation,","18 Years",{"count":55,"type":22},154,"INTERVENTIONAL",[58],"NA","Context :\n\nModerate to severe head trauma with altered state of consciousness is an extremely common pathology (between 60 and 120 cases per 100 000 people per year depending on the country and age group), and is responsible for 30% of deaths by trauma. It is complicated in 30-60% of cases by subarachnoid hemorrhage (SAH), which makes it the leading cause of SAH. SAH and its complications are well described when the origin is aneurysmal, notably cerebral vasospasm (CV) because it promotes delayed cerebral ischemia with a major prognostic impact. This is why the screening and prevention of this vasospasm are well established in the literature and in practice, in the nosological context of aneurysmal SAH.\n\nResearch problem :\n\nHowever, when it comes to post-traumatic SAH, CV is a more maligned entity, with a much less detailed description. However, when we know the prognostic interest that it could have for patients, it seems legitimate to seek to define its physiopathological and epidemiological contours. On a prospective cohort of 290 subjects, Oertel et al. (2005) demonstrated, in head trauma patients, an incidence of approximately 40% of compatible signs with the recognized criteria of CV.\n\nTo date, the literature remains sparse on this subject.\n\nProposed study :\n\nIn view of the incomplete scientific literature, the study team wish to carry out a prospective epidemiological study in moderate to severe head trauma patients complicated by SAH and hospitalized at the Martinique University Hospital, with the aim of better characterizing the incidence of the occurrence, and evolution of CV with clinical impact in these patients.\n\nOne of the original aspects of the proposed study is the use of CT scan with perfusion sequence, which has shown its superiority to Transcranial Doppler. The other particularity is its prospective aspect and triggered by an alteration in the clinical state of the patient presenting a traumatic SAH, then directly linking the pathophysiology (cerebral ischemia) and the clinical impact. Thus, the diagnosis of traumatic CV will be made on a cerebral CT scan by the association of the 50% reduction in the caliber of one or more cerebral arteries and a perfusion defect in the perfusion sequence in a context of alteration of neurological clinical examination or deterioration of neurological monitoring parameters. Finally, few studies have monitored the evolution of these patients at 1 and 6 months after the initial event.\n\nHypothesis :\n\nThe research hypothesis is that in the population of moderate to severe head trauma patients hospitalized at the Martinique University Hospital, when a new neurological symptomatology or a deterioration in the state of consciousness occurs, it could be a post-truamatic CV in 15 to 20% of cases.\n\nIndeed, the rare studies find frequencies of radiologically confirmed CV in head trauma patients of around 30-45%, with low numbers of subjects, retrospective studies, or not correlated with the clinic and with the clinical and paraclinical data necessary for the positive diagnosis of this entity. The reported frequency of traumatic CV with clinical impact ranges between 15-20%.\n\nThe study team therefore expect an incidence of 15 to 20% of CV with clinical impact in patients with traumatic SAH in Martinique. CV could be responsible for sudden deterioration of the neurological state in patients suffering from traumatic SAH between the 3rd and 12th day inclusive of treatment (according to retrospective studies already carried out) and responsible for its specific morbidity linked to cerebral ischemia localized in the spasmed area manifested by a worsening of the neurological prognosis on the modified Rankin scale.",[61,62,27,63],"SAH (Subarachnoid Hemorrhage)","Cerebral Vasospasm","Severe Traumatic Brain Injury",[61,62,65,66,67],"Moderate and severe Traumatic Brain Injury","CT scan","Cerebral perfusion","2025-03-26",{"date":70,"type":37},"2025-03-31",{"date":72,"type":37},"2024-11-06",{"date":74,"type":22},"2028-12-06",{"name":76,"class":77},"University Hospital Center of Martinique","OTHER"]