Clinical Trials

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.

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 develop an MRI based model to accurately identify persistent posttraumatic headache related to mild traumatic brain injury, as different from chronic migraine.

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

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

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).

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.

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

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

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 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 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 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 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).

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 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.

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 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:

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

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 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 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 ...