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200 active trials for Traumatic Brain Injury

Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS

Introduction: Patients suffering a time-critical medical condition require rapid prehospital assessment and treatment and most often quick transportation to definitive care. This can be decisive for patient outcome. In order to minimize time from assessment to treatment, thus lowering mortality and morbidity, it is important to have a well-coordinated chain of care. The efficient use of Ground Emergency Medical Services (GEMS) and Helicopter Emergency Medical Services (HEMS) is essential in such a chain of care. Objectives: The aim is to describe differences in mortality, morbidity, assessment and treatment of two time-critical conditions, traumatic brain injury (TBI) and acute myocardial infarction (MI), in patients assessed by GEMS and HEMS respectively. Method: The project consists of a descriptive observational study and comparative cohort study. Inclusion criteria are patients considered to be suffering from TBI and acute MI, which are treated by GEMS or HEMS in the regions of Uppsala, Jämtland/Härjedalen, Dalarna and Värmland. Clinical significance: The results expect to be the basis for further studies aiming to optimize the utilization of GEMS and HEMS.

Start: September 2019

Neuromodulatory Treatments for Pain Management in TBI

Traumatic brain injury (TBI) and chronic pain are common and serious health problems for military veterans and often co-occur, leading to poor post-deployment adjustment. Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus, there is an urgent need to develop pain management approaches that are effective, overcome barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce pain-related symptoms and have the potential to be developed into self-directed treatments through use of mobile technology.

Start: September 2018

Cortical Spreading Depolarization After Severe Traumatic Brain Injury

Preliminary evaluation of electrodes placed on the brain for recording brain activity and novel algorithms to determine cortical spreading depolarization foci of origination following severe traumatic brain injury requiring neurosurgical intervention.

Start: August 2019

Restorative Neuromodulation for Upper Extremity Functions

The objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury (TBI) or cervical spinal cord injury (SCI); and to find the physiological changes in the neuromuscular systems after this new intervention with high-resolution electrophysiology and biomedical imaging.

Start: May 2019

Training to Reconnect With Emotional Awareness Therapy

To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.

Start: May 2018

In-Field Detection of Intracranial Pressure

This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.

Start: February 2021

Improving New Learning and Memory in School Aged Children

The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.

Start: October 2017

Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)

The LITES Network is an operational trauma center consortium which has the expertise, track record and confirmed capabilities to conduct prospective, multicenter, injury care and outcomes research of relevance to the Department of Defense (DoD). Hemorrhage and Traumatic Brain Injury (TBI) are responsible for the largest proportion of all trauma-related deaths. It is the poly-trauma patient who suffers both hemorrhagic shock and traumatic brain injury where a paucity of evidence exists to direct treatment, limiting the development of beneficial trauma practice guidelines. The use of Whole Blood (WB) for early trauma resuscitation has been touted as the 'essential next step' in the evolution of trauma resuscitation. Despite its historical and more recent use, little is known regarding WB's benefit relative to the 'current practice' ratio-based blood component therapy in the acutely bleeding patient, and even less is known regarding its effects in patients with TBI. AIM#1: Evaluate patient centered outcomes associated with early whole blood resuscitation practice as compared to component resuscitation in poly-trauma patients with hemorrhagic shock and further characterize outcome benefits in those with traumatic brain injury. AIM#2: Characterize blood pressure and resuscitation endpoints during the acute resuscitation phase of care and the associated/attributable outcomes for traumatic brain injury in patients with hemorrhagic shock. General Hypothesis #1: Whole blood resuscitation will be associated with improved mortality and resuscitation outcomes in poly-trauma patients and long term neurological outcome in those patients with traumatic brain injury as compared to those resuscitated with component therapy. General Hypothesis #2: Differences in prehospital and acute phase resuscitation systolic blood pressure will be associated with differential outcomes in patients with traumatic brain injury at discharge and at 6 months. Study Design: The LITES network will perform a multicenter, prospective, observational cohort study over a 4 year period to determine the impact of whole blood resuscitation in trauma patients with hemorrhagic shock at risk of large volume resuscitation with and without TBI. Early whole blood resuscitation will be compared to standard component resuscitation. The study will also further characterize blood pressure and resuscitation endpoints in poly-trauma patients with traumatic brain injury. Six Trauma sites with appropriate characteristics will be selected from 12 LITES Network sites across the country. Study Setting: The study will be performed utilizing busy level I trauma centers within the LITES Network located across the country, at sites where either whole blood has currently been incorporated into standard of care or where component blood transfusion is being utilized for patients in hemorrhagic shock at risk for large volume resuscitation. Study Population: The study will focus on patients who suffer blunt or penetrating injury, transported to a SWAT participating LITES trauma center with evidence of hemorrhagic shock at risk of large volume blood resuscitation.

Start: May 2018

Brain Injury Assessment Study at Hennepin County Medical Center

The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.

Start: May 2016

Multimodal Neuromonitoring

Theoretical Framework & Background Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions. Hypotheses Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue. Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue. The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome. Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status. Methods Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach. Level of originality Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.

Start: December 2020

Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

The aims of this traumatic brain injury (TBI) study are: to evaluate the short and long-term efficacy of two structured outpatient intervention programs, Resilience and Adjustment Intervention (RAI) vs. RAI with follow up booster sessions (RAI+) on resilience to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+ to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

Start: February 2018

Near Infra-red Spectroscopy for Detection of Intracranial Haematoma

Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants. Non-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these noninvasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources. Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as nearinfrared spectroscopy (NIRS) is to be investigated. The aim of this study is to determine the sensitivity and specificity of NIRS as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain. Study design is Prospective sensitivity and specificity study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited. Outcome measures including correlation of non-invasive monitoring with near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect. Secondary outcome including 30 days mortality and functional outcome at 3 months.

Start: April 2021

CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

The research aims of the CENTER-TBI study are to: better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and identify the most effective clinical interventions for managing TBI. Specific aims To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI. To refine and improve outcome assessment and develop health utility indices for TBI. To develop multidimensional approaches to characterisation and prediction of TBI. To define patient profiles which predict efficacy of specific interventions ("Precision Medicine"). To develop performance indicators for quality assurance and quality improvement in TBI care. To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder. To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR). To intensify networking activities and international collaborations in TBI. To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels. To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

Start: December 2014

Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Up to 28% of undergraduate college students report a suspected history of traumatic brain injury. Following traumatic brain injury, college students fail and repeat more courses and have lower grade point averages. Further complicating this problem may be the fact that college students lack knowledge of traumatic brain injury definition, its associated symptoms, and individuals involved in post-injury management. In this project, the investigators propose to compare the use of an established treatment model (i.e., the Dynamic Coaching Model) to a novel protocol (i.e., the Apprenticeship Approach) that includes explicit instruction about traumatic brain injury in college students with this population. The investigators will use a group comparison design to examine the efficacy of this instructional component. This work incorporates findings from educational psychology and speech-language pathology (e.g., the included instructional materials adhere to the principles of adult learning). As such, this work will advance the field's basic understanding of currently recommended treatment components and will systematically examine the effects of incorporating explicit instruction into an existing treatment model.

Start: January 2021

Diet Induced Ketosis for Brain Injury - A Feasibility Study

Each year, approx. 100 patients with severe brain injury is admitted to the Clinic for Neurorehabilitation/TBI Unit, Rigshospitalet. Severe brain injury results in local oxygen deficiency and acid formation in the brain, which together destroys brain cells. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with severe brain injury for six weeks. Ketosis has been shown to be neuroprotective during and after severe brain injury.

Start: October 2020

Detection of Cerebral Ischemia With a Noninvasive Neurometabolic Optical Monitor

The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow and metabolism monitor, by allowing physiologic and pharmacologic decisions based on real-time brain physiology, potentially will become an important tool for clinicians in their efforts to prevent additional brain tissue death in patients admitted with stroke, brain hemorrhage and traumatic brain injury.

Start: December 2015

The EBC Recovery Study

The purpose of this research study to find out if clinically unconscious acute traumatic brain injury patients that show brain activation on electroencephalogram (EEG) (bedside test) have better results and wake up in the future.

Start: June 2020

University of Pittsburgh Brain Health Initiative

This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.

Start: November 2019

Sarcopenic Obesity in Neurodisabilities

To describe the frequency and thresholds for sarcopenic obesity in neurodisabled persons and the fat and lean mass distribution based on various neurodisabilities

Start: May 2019

Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury

Patients with a history of traumatic brain injury (TBI) are at elevated risk for Alzheimer's disease and related dementias (ADRD). Improvements in TBI treatment may mitigate this risk. Complex motor activities, which combine physical and cognitive demands, have been shown to have well established neurocognitive benefits. This study seeks to address the need for novel TBI interventions optimized for adults with history of TBI by determining the effectiveness of an immersive computer game designed to integrating complex cognitive-motor interventions.

Start: January 2020