Clinical Trials

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 primary purpose of this study is to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider

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 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).

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 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 investigating the impact on the brain of knock-outs, technical knock-outs and chokes in mixed martial arts.

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 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 connect brain inflammation measured by biomarkers, with data from advanced EEG technology, and clinical outcomes to provide new predictive information about seizure activity in children with critical brain injuries and epilepsy.

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 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 determine if anesthesia after concussion is associated with cognitive dysfunction, and if recent concussion is a patient safety risk in the perioperative period

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 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.

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.

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.

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.

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

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 the evaluation of new tools and strategies for the clinical assessment, management, and rehabilitation of concussions.

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.

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

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 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.

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 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.