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TBI (Traumatic Brain Injury) clinical trials

View clinical trials related to TBI (Traumatic Brain Injury).

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NCT ID: NCT02525432 Active, not recruiting - Clinical trials for Brain Injuries, Traumatic

Autologous Stem Cell Study for Adult TBI (Phase 2b)

Start date: November 21, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous infusion of autologous BMMNC after severe TBI results in structural preservation of global gray matter (GM) volume and white matter (WM) volume and integrity; as well as select regions of interest in the corpus callosum. THe secondary objectives are to determine if autologous BMMNC infusion improves functional and neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI; evaluate spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up safety evaluations.

NCT ID: NCT02430324 Completed - Clinical trials for TBI (Traumatic Brain Injury)

The Multicenter Italian INCEPT (INfarto CErebrale Post-Traumatico) Study

Start date: December 2009
Phase: N/A
Study type: Observational

Traumatic brain injury (TBI) is a leading cause of death and disability worldwide (Ghajar, 2000). With an estimated annual incidence of up to 500 per 100,000 population and more than 200 hospital admissions per 100,000 admissions in Europe each year, TBI is a major challenge to public health (Lingsma, 2010). Mortality and morbidity after TBI depend on several factors, either associated with patients characteristics, the cause of TBI, the neurological and general severity and secondary brain insults, the structural brain alterations as diagnosed at brain computed tomography (CT) (Rosenfeld, 2012). The prognostic value of brain CT characteristics is well documented, including the status of basal cisterns, midline shift, the presence and type of intracranial lesions, and traumatic subarachnoid hemorrhage (Maas, 2008). Postraumatic cerebral ischemia, which includes functionally impaired yet still viable tissue, so-called ischemic penumbra, and irreversible cerebral infarction (PTCI), is frequent in patients who die after moderate or severe head trauma (Stocchetti, 2014). Evidence of antemortem occurrence of PTCI is limited to three single-center retrospective studies, reporting a varying prevalence of 1.9%, 8% and 19.1% (Mirvis, 1990; Marino, 2006; Tawil, 2008). Increased intracranial pressure (ICP), blunt cerebral vascular injury, need for craniotomy and treatment with recombinant activated factor VII, have been demonstrated to be risk factors for PTCI. In one study, PTCI was an independent risk factor for poor outcome after moderate or severe head trauma with a two-fold increase in mortality and severe disability (Marino, 2006). PTCI can be an important diagnosis in patients with significant TBI for various reasons. First, it might influence long-term outcome. Second, as an outcome that is measurable, and relevant to survival and lifestyle, PTCI could be used as an outcome measure in randomized controlled trials. Third, diagnosis of PTCI could be used as a standard diagnostic reference to validate early surrogate indicators of cerebral ischemia. The investigators therefore planned a multi-center prospective study to investigate the impact of PTCI on disability at hospital discharge, and on 6-month morbidity and mortality in a population of moderate and severe adult TBI patients. The investigators also evaluated the role of intracranial hypertension, decreased cerebral perfusion pressure, hypotension and other secondary ischemic insults in determining the appearance of PTCI.

NCT ID: NCT02425527 Completed - Clinical trials for Traumatic Brain Injury

Digital Gaming for Persons With Traumatic Brain Injury

PLAY
Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to determine whether digital games are effective and acceptable in the treatment for patients with traumatic brain injury.

NCT ID: NCT02392975 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Fast MR for Young Children With Traumatic Brain Injury

Start date: June 2, 2015
Phase: N/A
Study type: Interventional

This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI). In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disability and death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations. Fast MR is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR has not been validated in children with TBI, a critical gap. The investigators will measure feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old who undergo head CT for TBI. The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared to determine: 1) whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR without sedation can be performed quickly and successfully.

NCT ID: NCT02331628 Completed - Clinical trials for TBI Traumatic Brain Injury

ESWT as a Treatment for Chronic NHO in TBI Patients

Start date: October 2014
Phase: N/A
Study type: Interventional

Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.

NCT ID: NCT02251002 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Frontoparietal Priority Maps as Biomarkers for MTBI

Start date: July 2015
Phase:
Study type: Observational

The purpose of this study is to determine whether there is a quantitative relationship between brain processes seen by a MRI and visual deficits caused by mild to moderate traumatic brain injuries (mTBI).

NCT ID: NCT02003183 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy

Start date: March 2013
Phase:
Study type: Observational

This project was designed to determine brain imaging patterns using 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) with positron emission tomography (PET) in participants with suspected Chronic Traumatic Encephalopathy (CTE), a progressive degenerative disease of the brain found in people with a history of repetitive traumatic brain injuries (TBIs), characterized by personality, behavioral, and mood disturbances, cognitive impairment, and sometimes motor symptoms. Currently, CTE can only be definitely diagnosed from neuropathological examination of the brain after autopsy. Developing tools to assist in the detection of this condition in living individuals at risk would facilitate research focusing on discovering potential prevention and treatment strategies.

NCT ID: NCT01952288 Completed - Clinical trials for TBI-Traumatic Brain Injury

Simvastatin for mTBI

Start date: September 16, 2013
Phase: Phase 4
Study type: Interventional

Study of simvastatin in Iraq/Afghanistan Veterans with multiple blast exposure and mTBI. The study will measure substances in cerebrospinal fluid (CSF) that are related to dementing disorders.

NCT ID: NCT01948947 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Improving Functions in MTBI Patients With Headache by rTMS

Start date: May 2014
Phase: N/A
Study type: Interventional

Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches. This study aims to 1) assess the effect of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS with function magnetic resonance imaging (fMRI).

NCT ID: NCT01728831 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury

NIRSTBI
Start date: November 2012
Phase: N/A
Study type: Observational

This proposal aims to provide some objective, non-invasively achieved, physiologically relevant data in order to provide some rational basis for decision-making for transfusion in sTBI. Specifically this proposal is an observational study of transfusion and brain tissue saturation in sTBI patients. The results will illustrate to what degree brain tissue oxygenation is critically dependent on the degree of anemia in sTBI and help in the decision of whether transfusion might be helpful.