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

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02519998
• Other study ID #: 14D.611
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2015
• Last updated: August 6, 2015
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Thomas Jefferson University
• Contact: Mijail Serruya, MD, PhD
• Phone: 267-463-2300
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion

Intervention

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

Locations

Country	Name	City	State
United States	Jefferson Comprehensive Concussion Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical history indicative of concussion	Basic medical history demographics gathered during patient's regular clincal visit.	Upon enrollment	No
Secondary	Neurocognitive Testing and Assessment Batteries	Sports Concussion Assessment Tool (SCAT-3)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Balance Error Scoring System (BESS)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	King Devick Test	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Acute Concussion Evaluation (ACE)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Beck Depression Inventory (BDI)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Beck Anxiety Inventory (BAI)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	World Health Organization-Five Well-being Index (WHO-5)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Multidimensional Anxiety Scale for Children (MASC)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Spence Children's Anxiety Scale	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	"SCARED" Montgomery-Åsberg Depression Rating Scale	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	ImPACT	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Trails A and B Forward	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Reverse Digit Span	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Jefferson After Concussion Test (JACT)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Rivermead Post Concussion Symptom Questionnaire (RPQ)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Traumatic Brain Injury-Quality of Life (TBI-QOL)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Mayo-Portland Adaptability Inventory (MPAI-4)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Migraine Disability Assessment (MIDAS)	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Fatigue Severity Scale	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Epworth Sleepiness Scale	1 year	No
Secondary	Neurocognitive Testing and Assessment Batteries	Pittsburgh Sleep Quality Index	1 year	No
Secondary	Diagnostic Procedures	Galvanic skin response	1 year	No
Secondary	Diagnostic Procedures	Electrocardiography (EKG)	1 year	No
Secondary	Diagnostic Procedures	Electroencephalography (EEG)	1 year	No
Secondary	Diagnostic Procedures	Fundoscopy Optical Coherence Tomography (OCT)	1 year	No
Secondary	Diagnostic Procedures	Von Frey Sensory Filament Thresholds	1 year	No
Secondary	Diagnostic Procedures	BioSway	1 year	No
Secondary	Biospecimens	Blood	1 year	Yes
Secondary	Biospecimens	Siliva	1 year	Yes
Secondary	Biospecimens	Urine	1 year	No
Secondary	Clinically Acquired Imaging	CT, MRI	1 year	No
Secondary	Opthalmologic	Fundoscopic photographs	1 year	No
Secondary	Opthalmologic	Optical coherence tomography	1 year	No
Secondary	Tactile Sensation	Von Frey sensory thresholds	1 year	No