View clinical trials related to TBI.
Filter by:Hypothesis 1: On fMRI scanning, frontoparietal activation during performance of executive function tasks of working memory, inhibitory control processes, and stimulus-response interference will exhibit greater signal intensity, a wider spatial extent, and more bilateral activation in chronic MTBI than chronic OI participants. Hypothesis 2: DTI changes, characterized by lower FA and higher MD at the gray-white junction, corpus callosum, central semiovale, and internal capsule, will be seen in MTBI but not in OI subjects. Hypothesis 3: Increased fMRI activation in chronic MTBI will be correlated with location and severity of disrupted fiber tracks that subserve neural networks associated with each fMRI activation task. Hypothesis 4: Performance on computerized neuropsychological testing (ANAM) and reaction time measures on fMRI tasks will better discriminate MTBI from OI than standard paper-and pencil tests. Hypothesis 5: The combination of fMRI, DTI, and ANAM will better discriminate MTBI from OI than each individual method. Hypothesis 6: More severe brain pathology in MTBI, as measured by neuroimaging (fMRI, DTI) and ANAM test scores, will be associated with less severe PTSD and symptoms.
We use Transcranial magnetic stimulation (TMS), combined with simultaneous registration of electroencephalograph (EEG),for examining human cortical functionality. TMS-EEG is a noninvasive brain stimulation method that allows to study human cortical function in vivo. EEG provides an opportunity to directly measure the cerebral response to TMS, measuring the cortical TMS Evoked potential (TEP). In this study we measure TEPs, in a wide variety of neurological conditions and healthy as a measure of cerebral reactivity across wide areas of neocortex.
The first aim of this study is to investigate the frequency and severity of a specific pathological metabolic pattern, mitochondrial dysfunction, of the brain in comatose patients under neurocritical care. This pattern is recognized as a complication after compromised blood flow to the brain and may be amenable to treatment. The other main aim of this study is to correlate patterns of metabolites between brain and jugular venous blood. It is probable but not proven that jugular venous microdialysis can mirror the global metabolic state of the brain.
This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.
SPECIFIC AIMS While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore, post-concussive symptoms commonly co-occur with affective symptoms including depression and anxiety which when present can prolong recovery from primary post-concussive symptoms. Together, persistent physical and psychological symptoms confer protracted functional impairment and create a significant burden for affected youth, their family, and school. Currently, there are no evidence-based guidelines to inform treatment of persistent post-concussive symptoms in youth and adolescents. In response to the dearth of evidence-based treatment approaches for youth with persistent post-concussive symptoms, the investigators developed a novel collaborative care treatment model that simultaneously targets post-concussive symptoms and co-occurring depression and anxiety. Athletes and their family members receive patient navigator care management services that bridge post-injury care across acute care, specialist and primary care health service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain symptomatic after initial treatment efforts receive stepped-up care that may include psychopharmacologic consultation. The Investigators have demonstrated feasibility of the intervention model through a pilot randomized-control trial of 49 adolescents with persistent post-concussive symptoms recruited from a regional children's hospital. Participants assigned to the intervention condition demonstrated significant and clinically-meaningful reductions in post-concussive and depressive symptoms as well as health-related quality of life as compared to adolescents in the usual care arm of the trial.
This is a Phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after TBI.
The investigators will longitudinally measure cerebrovascular reactivity (CVR) by functional near-infrared spectroscopy (fNIRS) in acute (≤3 days from injury), subacute, and chronic phases after TBI as a biomarker of TCVI as compared to healthy controls. CVR will be measured by fNIRS response to hypercapnia. The investigators hypothesize that CVR will be decreased after TBI and that these decreases will correlate with clinical outcomes. Furthermore, the investigators predict that administration of a vasodilatory medication (sildenafil) will augment CVR after TBI.
Objectives: Mild traumatic brain injury (mild TBI) occurs frequently in combat personnel and has been linked to complaints of emotional symptoms in up to 85% of those injured, with high rates of PTSD symptoms, anxiety, depression, and mood swings. TBI may cause cerebral white matter injury and changes in white matter integrity have been correlated with behavioral changes even with very mild TBI. Patients with mild TBI also have higher rates of dishonorable discharge from the military, as well as substance abuse. Many of these behavioral changes are associated with alterations in frontal-subcortical networks, which are heavily dependent on white matter connectivity. Our primary goal in this investigation is to begin to understand the specific neurological mechanisms that may underlie emotional dysfunction following mild TBI. Research Plan: We will compare patients with PTSD but no TBI to patients with TBI with and without emotional symptoms. It may be that the basic emotional responses of these populations are different and that these differences may help elucidate the mechanism accounting for these changes in mood and emotional behaviors. Finding a neurological and injury-specific basis for the constellation of chronic emotional symptoms observed in this population could have treatment implications such that the treatment of patients with versus those without injury induced PTSD may have different efficacies (e.g., exposure therapy may work best for the patients with non-injury related PTSD). Methods: We will recruit 60 subjects with mild TBI from our OEF/OIF poly-traumatic and 60 controls (30 with PTSD but no TBI). We will test emotional behaviors using an affective neuroscience methodology with indicators chosen based on the reported symptoms profiles in this population. Specifically, we will assess the relationship between white matter injury in the uncinate fasciculus and anterior limb of the internal capsule and alteration of affective response physiology (e.g., startle response while viewing high intensity positively and negatively valecned visual scenes) and cognitively (identification of the 6 primary emotions including ratings of intensity and arousal). To determine the integrity of white matter pathways, we will use high-resolution diffusion weighted imaging (DWI) with diffusion tensor imaging (DTI) and related analysis techniques.
This retrospective study is a more extensive, confirmatory analysis of the cognitive and functional outcomes initially seen in 2 groups of MCI/dementia patients in Springfield, MA and compares specialized dementia care and a comprehensive treatment approach versus usual care delivered in a non-specialist setting. The first group of patients (n= 328) was seen by a dementia specialist, who utilized a standardized assessment and treatment protocol (CNS). This included comprehensive identification and treatment of hypoxia, sleep-disorders, and other cognitively-impairing metabolic conditions as well as maximally- dosed FDA-approved medications for dementia, depression, and PBA. The second group of patients (n= 280) was seen by non-dementia specialists in the community and received usual care which did not include comprehensive assessment or treatment of underlying metabolic derangements or maximal utilization of currently available medications. This study, evaluating date from a larger cohort (n>800) of specialist-treated cognitively-impaired patients, will further examine the hypothesis that a comprehensive dementia treatment protocol yields cognitive stabilization and/or improvement using already available dementia drugs when compared with usual community care.
Traumatic brain injury (TBI) is a major public health problem with an annual incidence of about 1.7 million per year. TBI is associated with various long-term morbidities. Among them, psychiatric disturbances are the major cause of chronic disability and poor quality of life. Major depression is the common psychiatric sequela post TBI with rates ranging from 13% at 1 year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred to as TBI depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such as anxiety, aggression, substance abuse and cognitive deficits that often makes treatment difficult. Despite increased rates of depression, there is no Food and Drug Administration (FDA) approved drug/s for its treatment. The investigators propose to address these limitations by use of a novel serotonergic agent, vortioxetine, which has a multimodal mechanism of action through serotonin transporter (SERT) inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor partial agonism, and 1A receptor agonism. Overarching Goal: The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid NPS. Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for screen failures. Written informed consent will be obtained from these patients. Subjects will be followed for a total of 12 weeks. Subjects will be randomized to either the vortioxetine arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine 10mg per day, which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1 or 2 visits) and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline Relevance: This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities. If found to be effective, results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging.