View clinical trials related to Traumatic Brain Injury.
Filter by:Severe traumatic brain injury (STBI) is a leading cause of disability, mortality, and economic burden worldwide. The impact of severe traumatic brain injury (STBI) on the economy of developing countries like Pakistan is distressing. Pakistan has a large proportion of the young adult population in the World. Motorbike is the most common locomotive vehicle. These young ones are in the economically productive part of their lives. Their loss is an economical set back not only for their families but also for the Nation. Patients with STBI need standardized management in Neuro-critical care unit (NCCU). Although the setup and maintenance cost of an effective NCCU is one of the major burden on the budget of any public sector hospital, but the young survivor in turn can be productive for the Nation. During mechanical ventilation, severe traumatic brain injury patients frequently develop ventilator-associated pneumonia (VAP). Ventilator-associated pneumonia can be evaluated using Clinical pulmonary infection score (CPIS). CPIS is considered as an important clinical indicator of pneumonia in NCCU. Bronchoalveolar Lavage (BAL) is a minimally invasive procedure done with instillation of normal saline into subsegments of the lung followed by suction and collection of the instilled fluid for analysis with flexible bronchoscope. Patients with moderate and severe traumatic brain injury usually present with altered conscious level, and most of them already have aspiration of vomitus, debris and secretions which increase the risk of VAP in them. Bronchoalveolar lavage can be helpful in preventing this dreadful VAP by clearing the airways. The aim of this study is to find out the effect of early Bronchoalveolar Lavage on severity of development of VAP assessed through clinical pulmonary infection score (CPIS) in TBI patients.
Depression is common after traumatic brain injury (TBI) and may have wide-ranging consequences. Post-TBI depression may impede reintegration into the family and community and lead to lower quality of life and heightened suicide risk. It may also interfere with rehabilitation. Yet, current treatments for post-TBI depression are based largely on expert opinion rather than evidence from rigorous studies. Behavioral activation (BA) is a promising intervention for post-TBI depression. It is a brief behavioral treatment that helps people define goals, create and execute plans to reach them, and engage in meaningful activities. BA has been tested in clinical trials since the 1970s and has been shown to reduce or prevent depression in populations with diverse medical conditions. However, BA has rarely been used or studied for treatment of depression in a TBI population. The investigators will conduct a study of BA with 40 Veterans with TBI and depressive symptoms in VA outpatient rehabilitation care. One group of Veterans will be randomly assigned to receive BA plus usual care. The BA program consists of six sessions delivered over three months at the VA (or Veterans' homes, if preferred) by an occupational therapist (OT). A second group of Veterans will be randomly assigned to receive usual care. The investigators will assess the feasibility of delivering the BA intervention in the rehabilitation setting and its acceptability to Veterans and staff. The research team will also assess participant responses to BA in the outcomes of depressive symptoms, community reintegration, and quality of life. Study findings will be used to guide the development of a future study of BA in a larger sample of Veterans with post-TBI depression. This study and future research may add a powerful clinical tool to rehabilitation services to lessen or prevent depression in Veterans with TBI. Reducing depression may in turn facilitate rehabilitation and enhance community reintegration, allowing Veterans to engage more fully in their families and communities.
Spontaneous hyperventilation is common in severe traumatic brain injury patients and correlates closely with poor outcomes. How to treat this pathological condition remain unsolved. Remifentanil is a frequently used short-acting opioid, has the potent side-effect of dose-dependent respiratory inhibition. Specifically, it prolongs the expiratory time only and does not influence the respiratory drive. Among the safety range, the investigators will determine an ideal dose of remifentanil to maintain PaCO2 between 35 to 45 mmHg. The investigators will monitor the cerebral blood flow of the middle cerebral artery and the internal carotid artery to validate cerebral perfusion improvement.
21 healthy control participants will be recruited. On Day 1 they will complete reward-guided decision making tasks and questionnaires followed by a functional magnetic resonance imaging (fMRI) scan. On Days 2 and 3 they will receive repetitive transcranial magnetic stimulation (rTMS) targeting a specific part of the brain called the dorsal anterior cingulate cortex (dACC) or sham stimulation, and will then repeat a subset of the same decision making tasks and fMRI sequences. If brain stimulation modifies decision making and dACC activity, it could represent a novel way of treating patients with neural circuit deficits that impede motivated behavior. Of particular relevance to the current trial, this rTMS study will run in parallel with a study of apathy (i.e., diminished motivation) in patients with traumatic brain injury (TBI), with the goal of eventually leading to a patient-centered trial of rTMS treatment for this disruptive neuropsychiatric symptom.
Acute brain injury due to traumatic brain injury (TBI), intracerebral haemorrhage (ICH), and aneurysmal subarachnoid haemorrhage (SAH) carries a high morbidity and mortality, in part due to the development of secondary brain injury. The mechanisms behind secondary brain injury are incompletely understood, but oxidative/nitrosative stress and disturbances in the metabolism of the vasodilator nitric oxide (NO) are believed to be involved. The aim of the present study is to characterise systemic changes in markers of oxidative/nitrosative stress and NO metabolism in the early phase after acute brain injury, and to examine their relationship to clinical course, neurological outcome, and mortality.
The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial
This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients with mild-to-moderate traumatic brain injury (TBI) to prevent the progression towards immunokine storms, systemic inflammatory response syndrome (SIRS), severe respiratory distress, and requirement for invasive mechanical ventilation, and death, when compared to SOC alone (the control arm).
The primary objective of this study is to evaluate the feasibility and safety of using the ketogenic diet (KD) in children who sustained moderate to severe traumatic brain injury (TBI). The secondary objective is a preliminary evaluation of the outcomes of children who have had the standard of care plus the KD, compared to those with standard of care alone. Outcome measures for the secondary objective will include: need for ventriculoperitoneal shunt, duration of unconsciousness, need for any type of craniotomy, duration of post-traumatic amnesia, acute hospitalization length of stay, and cognitive and motor function at 12 months after injury. If this study demonstrates feasibility and safety, the information related to outcomes will be used to inform the planning of a future, larger, randomized study of the efficacy of the KD in children and adolescents with TBI. Specifically, this information will be used to assist with sample size calculations for this future study.
Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge. Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.
The Bioness Integrated Therapy System (BITS) (Bioness Inc. Valencia, CA) Touch Screen is an FDA approved device comprised of an interactive touchscreen and diverse program options to challenge patients through the use of visual motor activities, visual and auditory processing, cognitive skills, and endurance training. The purpose of this study is to enroll a small group of adults currently undergoing inpatient rehabilitation, who were admitted for an acute neurological event and present with an acute neurological visual field impairment. The primary objective is to compare any increase in visual field awareness using a prescribed regimen consisting of conventional vision exercises compared with a regimen using BITS touch screen technology. Participants will be alternately assigned into "A" and "B" groups upon enrollment. The control group "A" will be prescribed conventional (table top, pen and paper) vision interventions provided by an occupational therapist and will receive pre- and post- assessment of visual field awareness. Treatment group "B" will include a prescribed regimen with use of BITS touch screen technology. Group B participants will receive the same pre- and post- assessment of visual field awareness as Group A participants. The hypothesis is that incorporation of the BITS touch screen technology, being more interactive, will result in better outcomes for visual field awareness. This is an unblinded quasi-randomized control trial that will determine best treatment intervention for visual field impairment. Safety will be measured by the number of reported adverse events. The study period will include 6 sessions per participant, conducted at one site, with the objective of enrolling at least 30 participants to have 15 participants in each study group.