- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19112
- Rekrytering
- Jefferson Comprehensive Concussion Center
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Kontakt:
- Mijail Serruya, MD, PhD
- Telefonnummer: 267-463-2300
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Medical history indicative of concussion
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Neurocognitive Testing and Assessment Batteries
Tidsram: 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
Tidsram: 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
Tidsram: 1 year
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King Devick Test
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 year
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ImPACT
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsram: 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
Tidsram: 1 year
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Reverse Digit Span
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 year
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Fatigue Severity Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsram: 1 year
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Epworth Sleepiness Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Tidsram: 1 year
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Pittsburgh Sleep Quality Index
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1 year
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Diagnostic Procedures
Tidsram: 1 year
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Galvanic skin response
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1 year
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Diagnostic Procedures
Tidsram: 1 year
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Electrocardiography (EKG)
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1 year
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Diagnostic Procedures
Tidsram: 1 year
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Electroencephalography (EEG)
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1 year
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Diagnostic Procedures
Tidsram: 1 year
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Fundoscopy Optical Coherence Tomography (OCT)
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1 year
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Diagnostic Procedures
Tidsram: 1 year
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Von Frey Sensory Filament Thresholds
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1 year
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Diagnostic Procedures
Tidsram: 1 year
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BioSway
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1 year
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Biospecimens
Tidsram: 1 year
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Blood
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1 year
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Biospecimens
Tidsram: 1 year
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Siliva
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1 year
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Biospecimens
Tidsram: 1 year
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Urine
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1 year
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Clinically Acquired Imaging
Tidsram: 1 year
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CT, MRI
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1 year
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Opthalmologic
Tidsram: 1 year
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Fundoscopic photographs
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1 year
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Opthalmologic
Tidsram: 1 year
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Optical coherence tomography
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1 year
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Tactile Sensation
Tidsram: 1 year
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Von Frey sensory thresholds
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1 year
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mijail Serruya, MD, PhD, TJUH
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14D.611
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