Clinical Trials

The purpose of this study is to look at the blood’s clotting response in people who have suffered a traumatic injury and compare it with non-injured people.

The purpose of this study is to understand the lived experience of physical therapy rehabilitation for older adults after being seriously injured by a fall, requiring hospitalization.

The purpose of this research study is to look at how trauma affects the ability of blood to clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this research study will look at blood drawn from people after they suffer a traumatic injury to see how well their blood clots.

The purpose of this study is to retrospectively review experiences with thoracic endovascular aortic repair (TEVAR) of blunt traumatic thoracic aortic injury (BTAI) and to define the long-term outcomes from endovascular management at a single vascular center.

The purpose of this study is to evaluate the safety and tolerability of the Humacyte HAV in vascular trauma patients undergoing surgery for vascular replacement or reconstruction and to determine the rate of primary patency at 30 days.

The purpose of this study is to compare the effectiveness of intravenous (IV) infusions of MT-3921 to placebo in treatment of subjects with acute traumatic cervical spinal cord injury.  The study assesses the effect of MT-3921 on sensory and motor impairment, prehension impairment, and functional outcomes and independence in activities of daily living and quality of life, the safety and tolerability of MT-3921, and will characterize the pharmacokinetics profile of MT-3921 following multiple-dose administration in subjects with spinal cord injury.

The primary purpose of this study is to provide a subset of data using protocols of tolerance to lower-body negative pressure for validation of a commercially available wearable device that will be used in predicting hemorrhagic shock in persons suffering civilian and battlefield trauma.

Taking in-clinic measures of elbow flexor electromyography from individuals who have had surgical brachial plexus reconstruction to aid in the design of a future upper extremity assistive orthosis.

The purpose of this study is to investigate the outcomes for middle-aged and elderly patients who have a traumatic shoulder dislocation resulting in a bony Bankart injury.

Visually Evoked Potentials (VEPs) are electrical potentials elicited from brief visual stimuli and recorded from the visual cortex with surface electrodes.  VEPs are an objective, reliable, and non-invasive method for evaluation of the functional integrity of the retina and early afferent visual pathways. The purpose of this study is to compare the VEPs generated from a standard clinical evoked potential system to those obtained from the Vivonics portable VEP system.

The overall goal of this study is to help discover and better understand why some children with intellectual  and developmental disabilities self-injure.

This purpose of this pilot study is to determine if there are changes in mild TBI detectible with MRE. This is the first time this novel technology has been applied to mild TBI and the anticipated results are theoretical.

The purpose of this study is to evaluate performance of already developed porcine algorithms in the human “models” of lower body negative pressure (LBNP), and to obtain human model training and validation data sets from LBNP for further refinement of the algorithms.

The purpose of this study is to evaluate the utilization patterns and satisfaction of telemedicine on the sideline, and to evaluate the effect of sideline telemedicine on reducing unnecessary emergency department visits.

The purpose of this study is to develop an MRI based model to accurately identify persistent posttraumatic headache related to mild traumatic brain injury, as different from chronic migraine.

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED).

A study to test if Fremanezumab reduces headache in patients with Posttraumatic Headache (PTH)

The purpose of this study is to determine if nicotinamide riboside (750 mg/day for 12 weeks) can affect the levels of NAD+ in the brain as measured by 31P MRS.

Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12).

Primary hypothesis: The null hypothesis is that prehospital administration either of two dosing regimens of TXA in patients with moderate to severe TBI will not increase the proportion of patients with a favorable long-term neurologic outcome compared to placebo, based on the GOS-E at 6 months.

Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting ...

The purpose of this study is to address a knowledge gap. Early diagnosis of nerve root avulsion injuries following brachial plexus trauma remain a barrier to the early treatment of these complex injuries.  Traditionally, an observation period of 6 months following brachial plexus injuries has been utilized to allow for reinnervation.  Reinnervation is not possible in the setting of nerve root avulsion from the spinal cord and waiting for reinnervation in this setting unnecessarily delays treatment and potentially compromises outcome.  Having the ability to provide a real time evaluation of nerve root integrity would obviate the need of other more ...

This proposal aims to describe the oculometric features present during King-Devick (K-D) testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

Mayo Clinic has been funded by the National Institute on Disability & Rehabilitation Research (NIDRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes.

Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural ...

The purpose of this study is to determine if doing a lobectomy and decompressive hemicraniectomy together improves outcomes and decreases risk of death for patients after traumatic brain injury.

The purpose of this study is to assess long-term functional outcomes after pollicization.

The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.

The purpose of this study is to determine if the use of an anti-shear mattress overlay placed on a pre-hospital transport stretcher reduces shear forces and pressure on the skin, and increases patient comfort as compared to standard care.

The purpose of this study is to establish an aggregate database of information on the diagnosis, management (acute and definitive), surveillance and outcomes following blunt thoracic aortic injury.

The purpose of this study is to investigating the impact on the brain of knock-outs, technical knock-outs and chokes in mixed martial arts.

Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target ...

The purpose of this study is to demonstrate the value of our objective diagnosis of concussion (ODC) components and to quantify severity. ODC components include: the NeuroCatch™ Platform [quantified electroencephalogram (qEEG)] developed by NeuroCatch Inc., the King-Devick Test (in association with Mayo Clinic) of rapid number naming, and blood biomarkers such as neurofilament light (NfL), neuron-specific enolase (NSE), and S100B.  Wearable accelerometers (Triax Technologies’ SIM-G, X2 Biosystems X Patch, and Prevent Biometrics’ Impact Monitor Mouthguard) and three camera video footage will also provide acceleration data to correlate to concussive injuries and mechanism of injury. Time on Ice tracking will allow for ...

The purpose of the study is:

1. To determine the incidence of subclinical electrographic seizures and electrographic status epilepticus in children admitted to the PICU for head trauma, traumatic brain injury (TBI), and/or child abuse at National Children’s Hospital in Hanoi, Vietnam.

2. To determine whether a correlation exists between length of stay, morbidity, and mortality with incidence of subclinical SE and seizures.

The purpose of this study is to build on previous work, replicating the experimental protocol for subconcussive intervention with soccer headers, while adding EEG measurements and using modern machine learning (ML) techniques to create a highly accurate diagnostic algorithm.

The purpose of this study is to identify mechanisms and predictors for the persistence of post-traumatic headache and methods to treat post-traumatic headache and prevent its persistence.

The purpose of this study is to determine if there are changes in mild traumatic brain injury (mTBI) and/or repetitive head impacts (RHI) detectible with multiparametric MR Elastography (MRE). The hypothesis is that multiparametric MR Elastography will detect changes in the mechanical properties of human head tissues in patients following head traumas.

This study aims to describe the oculometric features extracted during K-D testing using eye-tracking that are associated with concussions in a youth sports population.

Concussion is a health issue impacting all athletes for which a clinical treatment protocol, other than rest, has not been established. The efficacy of such a treatment protocol relies heavily on an objective diagnosis and quantification of injury severity. We hypothesize our chosen objective diagnostic and injury quantification measures will show significant differences between non-concussed and concussed athletes to aid in future treatment protocols. We also hypothesize that data from individual exposure time, video footage, and personality measures will provide additional information to further characterize concussive injuries and support diagnostic and treatment protocols.

Headache is the most commonly reported symptom after trauma to the head. Although posttraumatic headache (PTH) shares some clinical characteristics with primary headache disorders, such as migraine, there are many unique features including head trauma and the exacerbation of headache with physical and cognitive stressors. The purpose of this study is to determine if subjects who have recently sustained a mild TBI and have PTH will have lower pain thresholds (i.e. hyperalgesia) and greater allodynia compared to healthy controls. The study will also determine if exposure to a bright light stressor will exacerbate hyperalgesia in subjects with mild TBI and PTH ...

The purpose of this study is to identify important physiologic trends in bedside ICU data such as cerebral perfusion pressure (CPP), intracranial pressure (ICP) using a bedside “Multimodal monitoring” (MMM) computer which utilizes ICM+ Cambridge software.

The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.

The purpose of this study is to conduct a comprehensive clinical and biomechanical screening of high school, collegiate-level, recreational, and Olympic/professional-level athletes with the goal of identifying individual functional and performance deficits that lead to future injury.

The purpose of this study is to investigate whether recent, groundbreaking discoveries about key pathophysiologic processes that drive chronic dizziness in patients without traumatic brain injury (TBI9,10) are applicable to patients with post-mTBI vestibular disability. We expect the results of this project to have practical clinical and research applications, providing novel data for two future steps:

The purpose of this study is to further demonstrate the value of the components of our objective diagnosis and quantification of severity: the NeuroCatch quantified electroencephalogram, the King-Devick test, blood biomarkers, and metabolomics profiling. Wearable accelerometers (Triax SIM-G) and video footage will provide data to correlate concussive injuries with physical parameters and mechanisms of injury. Time on Ice tracking will allow for calculation of Individual Exposure Time (IET).

The purpose of this study is the evaluation of new tools and strategies for the clinical assessment, management, and rehabilitation of concussions.

This study will investigate sub-concussions, concussions, and pre-syncopal choking episodes in a number of fighters using King Devick Test (KDT). We will also explore the immediate and long term consequence on the KDT results after a concussion or a pre-syncope have occurred.

The goal of our study is to validate KDT in Mixed martial arts (MMA), to propose the adoption of the KDT in the State of Minnesota to detect immediate cognitive decline during the amateur and pro-fighting event.

The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.

The purpose of this study is to investigate the reliability of a mobile app to assess balance in athletes during a concussion assessment

The specific aim of this project is to systematically and prospectively collect and collate data derived from the clinical care of concussion patients seen at Mayo Clinic Arizona.

The purpose of this study is to compare the use of the King-Devick concussion test in the traditional neutral (forward facing) position, to a 45 degree turn of the neck to the left and right.

Almost one-half million people suffer venous thromboembolism annually in the United States, and one-third die from this disease. Massive bleeding from injury accounts for half of early deaths after trauma. This study aims to prevent the deaths and suffering associated with venous thromboembolism and bleeding by identifying the individual person at high risk of these complications in order to take preventive measures.

The purpose of this study is evaluate changes in male and female athletes’ brains following concussion injury and recovery, and to see whether female athletes demonstrate a different pattern of recovery compared to male athletes.

Study summary:

The overall plan for this study is to conduct qualitative interviews among 40 family members of patients who have been hospitalized in a coma. Subjects for this study will be recruited by local site P.I.s from intensive care units at the following 18 U.S. centers:

All interviews will be conducted virtually via video conferencing by study staff at the Yale School of Medicine and Massachusetts General Hospital. All study activities following the interviews, including data analysis and manuscript writing, will take place at the Yale School of Medicine and Massachusetts General Hospital. We expect ...

The purpose of this study is to develop and test the effectiveness of an investigational imaging technique called magnetic resonance elastography (MRE) to measure the stiffness (mechanical properties) of tissues.

The purpose of this study is to study the structure and biochemistry of the brain and/or bodily fluid and tissue after death.  Comparison of specimens from normal and diseased individuals provide essential clues that lead to a greater understanding of the diseased state which, in turn, will lead to new ideas for therapy.

The purpose of this study is to evaluate safety and efficacy and show non-inferiority of the investigational PERFORM Stemless Reverse device to the control PERFORM Stem Reverse device in subjects who are candidates for the treatment of noninflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, rotator cuff tear arthropathy, correction of functional deformity, and post-traumatic arthritis.

The aim of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida. The Center will collect and store detailed phenotypic information, DNA, and other biofluids on affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid ...