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Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development

Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02519998
Enrollment
1000
Registered
2015-08-11
Start date
2015-03-31
Completion date
2016-12-31
Last updated
2015-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion

Keywords

Biomarkers, Electrocardiography, Balance, Neuropsychiatric assessment, Cortisol, Calcitonin-gene-related peptide, Electroencephalography, Optical coherence tomography, Von Frey Testing

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.

Interventions

OTHERConcussion

Study groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study)

Sponsors

Rothman Institute Orthopaedics
CollaboratorOTHER
Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Medical history indicative of concussionUpon enrollmentBasic medical history demographics gathered during patient's regular clincal visit.

Secondary

MeasureTime frameDescription
Diagnostic Procedures1 yearGalvanic skin response
Biospecimens1 yearBlood
Neurocognitive Testing and Assessment Batteries1 yearSports Concussion Assessment Tool (SCAT-3)
Opthalmologic1 yearFundoscopic photographs
Tactile Sensation1 yearVon Frey sensory thresholds
Clinically Acquired Imaging1 yearCT, MRI

Countries

United States

Contacts

Primary ContactMijail Serruya, MD, PhD
267-463-2300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026