Brain Concussion Clinical Trial
Official title:
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.
Concussions comprise a type of mild traumatic brain injury in which mechanical forces
disrupt brain metabolism causing transient neurological symptoms.
At the current time, there is no universally agreed-upon objective biomarker or risk
calculator of concussion upon which physicians can prognosticate future risk, identify
optimal treatments, and for sports medicine physicians, decide if and when a particular
player were safe to be returned to play.
While the majority of patients experience a full recovery within a few weeks of a
concussion, several going on to have chronic, debilitating symptoms, and all patients
experience a permanently increased risk of experiencing more debilitating and long-lasting
symptoms with each subsequent concussion. For certain people with certain genetic (e.g.,
ApoE status) and psychosocial (e.g., alcohol abuse, depression) risk factors, even a single
concussion can put them at greater risk for earlier and more severe forms of dementia
decades hence.
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of
diagnostics on patients who have had a concussion, repeating some of these tests serially
over time, so that the investigators may then in the future perform retrospective data
mining to determine if there were a biomarker or risk calculator that could be used to guide
return-to-play and other medical decisions.
This study plans to collect biological specimens (blood, saliva, urine, hair follicles),
electrophysiological (EEG, EKG), imaging (HCT, MRI, PET, SPECT), ambulatory (actigraphy),
sensory thresholds (Von Frey), ophthalmologic (fundoscopic photographs, OCT, SSVEPs),
vestibular (ENG, BESS, BioSway) along with demographic, medical history, medication,
psychosocial data and the results on validated instruments of cognition, mood, sleep, head
discomfort and quality of life.
Because it is important to determine the variability not only within the concussion group
but also between groups, the investigators will also recruit a control cohort, specifically
athletes who are already undergoing baseline cognitive testing pre-season. The clinical
focus of this study will be on concussed athletes, both children and adults, and the
investigators will also include non-sports patients who have mild traumatic brain injury due
to other situations including slip and fall, occupational, motor vehicle accidents, assault,
and blast exposure.
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Observational Model: Cohort, Time Perspective: Prospective
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