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.

Study Overview

• Status: Unknown
• Conditions: Brain Concussion
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19112
      • Recruiting
      • Jefferson Comprehensive Concussion Center
      • Contact: Mijail Serruya, MD, PhD; Phone Number: 267-463-2300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical history indicative of concussion	Basic medical history demographics gathered during patient's regular clincal visit.	Upon enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Rothman Institute Orthopaedics
• Investigators: Principal Investigator: Mijail Serruya, MD, PhD, TJUH

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Balance; Optical coherence tomography; Cortisol; Biomarkers; Electroencephalography; Electrocardiography; Neuropsychiatric assessment; Calcitonin-gene-related peptide; Von Frey Testing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 14D.611