- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19112
- Rekruttering
- Jefferson Comprehensive Concussion Center
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Kontakt:
- Mijail Serruya, MD, PhD
- Telefonnummer: 267-463-2300
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
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Study groups are differentiated based on presence of concussion.
No intervention is being made in either population (observational study)
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Non-concussed patients
Cohort control.
Primarily athletes who undergo routine pre-season baseline assessment
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Medical history indicative of concussion
Tidsramme: Upon enrollment
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Basic medical history demographics gathered during patient's regular clincal visit.
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Upon enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Sports Concussion Assessment Tool (SCAT-3)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Balance Error Scoring System (BESS)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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King Devick Test
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Acute Concussion Evaluation (ACE)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Beck Depression Inventory (BDI)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Beck Anxiety Inventory (BAI)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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World Health Organization-Five Well-being Index (WHO-5)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Multidimensional Anxiety Scale for Children (MASC)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Spence Children's Anxiety Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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"SCARED" Montgomery-Åsberg Depression Rating Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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ImPACT
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Trails A and B Forward
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Reverse Digit Span
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Jefferson After Concussion Test (JACT)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Rivermead Post Concussion Symptom Questionnaire (RPQ)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Traumatic Brain Injury-Quality of Life (TBI-QOL)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Mayo-Portland Adaptability Inventory (MPAI-4)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Migraine Disability Assessment (MIDAS)
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Fatigue Severity Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Epworth Sleepiness Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsramme: 1 year
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Pittsburgh Sleep Quality Index
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1 year
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Diagnostic Procedures
Tidsramme: 1 year
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Galvanic skin response
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1 year
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Diagnostic Procedures
Tidsramme: 1 year
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Electrocardiography (EKG)
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1 year
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Diagnostic Procedures
Tidsramme: 1 year
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Electroencephalography (EEG)
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1 year
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Diagnostic Procedures
Tidsramme: 1 year
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Fundoscopy Optical Coherence Tomography (OCT)
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1 year
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Diagnostic Procedures
Tidsramme: 1 year
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Von Frey Sensory Filament Thresholds
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1 year
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Diagnostic Procedures
Tidsramme: 1 year
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BioSway
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1 year
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Biospecimens
Tidsramme: 1 year
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Blood
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1 year
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Biospecimens
Tidsramme: 1 year
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Siliva
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1 year
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Biospecimens
Tidsramme: 1 year
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Urine
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1 year
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Clinically Acquired Imaging
Tidsramme: 1 year
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CT, MRI
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1 year
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Opthalmologic
Tidsramme: 1 year
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Fundoscopic photographs
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1 year
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Opthalmologic
Tidsramme: 1 year
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Optical coherence tomography
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1 year
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Tactile Sensation
Tidsramme: 1 year
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Von Frey sensory thresholds
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mijail Serruya, MD, PhD, TJUH
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14D.611
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