Clinical trial NCT02519998: Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Official title: Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Concussion
Keywords: Biomarkers
Electrocardiography
Balance
Neuropsychiatric assessment
Cortisol
Calcitonin-gene-related peptide
Electroencephalography
Optical coherence tomography
Von Frey Testing
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Rothman Institute Orthopaedics
First posted: 2015-08-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals ages 10 or older. If the patient has experienced a suspected concussion, must be a patient at the Jefferson Comprehensive Concussion Center.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients, 10 years of age or older with concussion being evaluated at the Jefferson Comprehensive Concussion Center in Philadelphia, PA, or by Jefferson Comprehensive Concussion Center physicians at other locations (including Rothman Institute sports medicine clinics in Bryn Mawr, PA, Marlton, NJ, Washington Township, NJ). The target population will be those with suspected concussions.

Exclusion Criteria:

* Patients not presenting at the Jefferson Comprehensive Concussion Center or affiliated locations.

Primary outcomes:
measure: Medical history indicative of concussion
timeFrame: Upon enrollment
Secondary outcomes:
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Neurocognitive Testing and Assessment Batteries
timeFrame: 1 year
measure: Diagnostic Procedures
timeFrame: 1 year
measure: Diagnostic Procedures
timeFrame: 1 year
measure: Diagnostic Procedures
timeFrame: 1 year
measure: Diagnostic Procedures
timeFrame: 1 year
measure: Diagnostic Procedures
timeFrame: 1 year
measure: Diagnostic Procedures
timeFrame: 1 year
measure: Biospecimens
timeFrame: 1 year
measure: Biospecimens
timeFrame: 1 year
measure: Biospecimens
timeFrame: 1 year
measure: Clinically Acquired Imaging
timeFrame: 1 year
measure: Opthalmologic
timeFrame: 1 year
measure: Opthalmologic
timeFrame: 1 year
measure: Tactile Sensation
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Comprehensive Concussion Center
state: Pennsylvania
Study officials:
affiliation: TJUH
name: Mijail Serruya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: