- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19112
- Rekrutierung
- Jefferson Comprehensive Concussion Center
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Kontakt:
- Mijail Serruya, MD, PhD
- Telefonnummer: 267-463-2300
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Medical history indicative of concussion
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Neurocognitive Testing and Assessment Batteries
Zeitfenster: 1 year
|
Sports Concussion Assessment Tool (SCAT-3)
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1 year
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Neurocognitive Testing and Assessment Batteries
Zeitfenster: 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
Zeitfenster: 1 year
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King Devick Test
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Zeitfenster: 1 year
|
Acute Concussion Evaluation (ACE)
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1 year
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Neurocognitive Testing and Assessment Batteries
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year
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ImPACT
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1 year
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Neurocognitive Testing and Assessment Batteries
Zeitfenster: 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
Zeitfenster: 1 year
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Reverse Digit Span
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1 year
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Neurocognitive Testing and Assessment Batteries
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year
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Fatigue Severity Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Zeitfenster: 1 year
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Epworth Sleepiness Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Zeitfenster: 1 year
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Pittsburgh Sleep Quality Index
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1 year
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Diagnostic Procedures
Zeitfenster: 1 year
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Galvanic skin response
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1 year
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Diagnostic Procedures
Zeitfenster: 1 year
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Electrocardiography (EKG)
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1 year
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Diagnostic Procedures
Zeitfenster: 1 year
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Electroencephalography (EEG)
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1 year
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Diagnostic Procedures
Zeitfenster: 1 year
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Fundoscopy Optical Coherence Tomography (OCT)
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1 year
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Diagnostic Procedures
Zeitfenster: 1 year
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Von Frey Sensory Filament Thresholds
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1 year
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Diagnostic Procedures
Zeitfenster: 1 year
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BioSway
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1 year
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Biospecimens
Zeitfenster: 1 year
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Blood
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1 year
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Biospecimens
Zeitfenster: 1 year
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Siliva
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1 year
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Biospecimens
Zeitfenster: 1 year
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Urine
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1 year
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Clinically Acquired Imaging
Zeitfenster: 1 year
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CT, MRI
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1 year
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Opthalmologic
Zeitfenster: 1 year
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Fundoscopic photographs
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1 year
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Opthalmologic
Zeitfenster: 1 year
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Optical coherence tomography
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1 year
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Tactile Sensation
Zeitfenster: 1 year
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Von Frey sensory thresholds
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1 year
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Mijail Serruya, MD, PhD, TJUH
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 14D.611
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