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

Sponsor

Thomas Jefferson University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02519998

Collaborator

Rothman Institute Orthopaedics (Other)

1,000

Enrollment

Location

21.1

Duration (Months)

47.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Concussion	Other: Concussion

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.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Concussed patients The clinical focus of this study will be on concussed athletes, both children and adults, and we 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.	Other: Concussion Study groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study)
Non-concussed patients Cohort control. Primarily athletes who undergo routine pre-season baseline assessment

Arm

Intervention/Treatment

Concussed patients

The clinical focus of this study will be on concussed athletes, both children and adults, and we 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.

Other: Concussion

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

Non-concussed patients

Cohort control. Primarily athletes who undergo routine pre-season baseline assessment

Outcome Measures

Primary Outcome Measures

Medical history indicative of concussion [Upon enrollment]
Basic medical history demographics gathered during patient's regular clincal visit.

Secondary Outcome Measures

Neurocognitive Testing and Assessment Batteries [1 year]
Sports Concussion Assessment Tool (SCAT-3)
Neurocognitive Testing and Assessment Batteries [1 year]
Balance Error Scoring System (BESS)
Neurocognitive Testing and Assessment Batteries [1 year]
King Devick Test
Neurocognitive Testing and Assessment Batteries [1 year]
Acute Concussion Evaluation (ACE)
Neurocognitive Testing and Assessment Batteries [1 year]
Beck Depression Inventory (BDI)
Neurocognitive Testing and Assessment Batteries [1 year]
Beck Anxiety Inventory (BAI)
Neurocognitive Testing and Assessment Batteries [1 year]
World Health Organization-Five Well-being Index (WHO-5)
Neurocognitive Testing and Assessment Batteries [1 year]
Multidimensional Anxiety Scale for Children (MASC)
Neurocognitive Testing and Assessment Batteries [1 year]
Spence Children's Anxiety Scale
Neurocognitive Testing and Assessment Batteries [1 year]
"SCARED" Montgomery-Åsberg Depression Rating Scale
Neurocognitive Testing and Assessment Batteries [1 year]
ImPACT
Neurocognitive Testing and Assessment Batteries [1 year]
Trails A and B Forward
Neurocognitive Testing and Assessment Batteries [1 year]
Reverse Digit Span
Neurocognitive Testing and Assessment Batteries [1 year]
Jefferson After Concussion Test (JACT)
Neurocognitive Testing and Assessment Batteries [1 year]
Rivermead Post Concussion Symptom Questionnaire (RPQ)
Neurocognitive Testing and Assessment Batteries [1 year]
Traumatic Brain Injury-Quality of Life (TBI-QOL)
Neurocognitive Testing and Assessment Batteries [1 year]
Mayo-Portland Adaptability Inventory (MPAI-4)
Neurocognitive Testing and Assessment Batteries [1 year]
Migraine Disability Assessment (MIDAS)
Neurocognitive Testing and Assessment Batteries [1 year]
Fatigue Severity Scale
Neurocognitive Testing and Assessment Batteries [1 year]
Epworth Sleepiness Scale
Neurocognitive Testing and Assessment Batteries [1 year]
Pittsburgh Sleep Quality Index
Diagnostic Procedures [1 year]
Galvanic skin response
Diagnostic Procedures [1 year]
Electrocardiography (EKG)
Diagnostic Procedures [1 year]
Electroencephalography (EEG)
Diagnostic Procedures [1 year]
Fundoscopy Optical Coherence Tomography (OCT)
Diagnostic Procedures [1 year]
Von Frey Sensory Filament Thresholds
Diagnostic Procedures [1 year]
BioSway
Biospecimens [1 year]
Blood
Biospecimens [1 year]
Siliva
Biospecimens [1 year]
Urine
Clinically Acquired Imaging [1 year]
CT, MRI
Opthalmologic [1 year]
Fundoscopic photographs
Opthalmologic [1 year]
Optical coherence tomography
Tactile Sensation [1 year]
Von Frey sensory thresholds

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts 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.