- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19112
- Nábor
- Jefferson Comprehensive Concussion Center
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Kontakt:
- Mijail Serruya, MD, PhD
- Telefonní číslo: 267-463-2300
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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.
|
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
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Medical history indicative of concussion
Časové okno: Upon enrollment
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Basic medical history demographics gathered during patient's regular clincal visit.
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Upon enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Sports Concussion Assessment Tool (SCAT-3)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Balance Error Scoring System (BESS)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
King Devick Test
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Acute Concussion Evaluation (ACE)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Beck Depression Inventory (BDI)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Beck Anxiety Inventory (BAI)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
World Health Organization-Five Well-being Index (WHO-5)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Multidimensional Anxiety Scale for Children (MASC)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Spence Children's Anxiety Scale
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1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
"SCARED" Montgomery-Åsberg Depression Rating Scale
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1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
ImPACT
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Trails A and B Forward
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Reverse Digit Span
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Jefferson After Concussion Test (JACT)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Rivermead Post Concussion Symptom Questionnaire (RPQ)
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1 year
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Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Traumatic Brain Injury-Quality of Life (TBI-QOL)
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1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Mayo-Portland Adaptability Inventory (MPAI-4)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Migraine Disability Assessment (MIDAS)
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1 year
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Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Fatigue Severity Scale
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Epworth Sleepiness Scale
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1 year
|
Neurocognitive Testing and Assessment Batteries
Časové okno: 1 year
|
Pittsburgh Sleep Quality Index
|
1 year
|
Diagnostic Procedures
Časové okno: 1 year
|
Galvanic skin response
|
1 year
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Diagnostic Procedures
Časové okno: 1 year
|
Electrocardiography (EKG)
|
1 year
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Diagnostic Procedures
Časové okno: 1 year
|
Electroencephalography (EEG)
|
1 year
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Diagnostic Procedures
Časové okno: 1 year
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Fundoscopy Optical Coherence Tomography (OCT)
|
1 year
|
Diagnostic Procedures
Časové okno: 1 year
|
Von Frey Sensory Filament Thresholds
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1 year
|
Diagnostic Procedures
Časové okno: 1 year
|
BioSway
|
1 year
|
Biospecimens
Časové okno: 1 year
|
Blood
|
1 year
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Biospecimens
Časové okno: 1 year
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Siliva
|
1 year
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Biospecimens
Časové okno: 1 year
|
Urine
|
1 year
|
Clinically Acquired Imaging
Časové okno: 1 year
|
CT, MRI
|
1 year
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Opthalmologic
Časové okno: 1 year
|
Fundoscopic photographs
|
1 year
|
Opthalmologic
Časové okno: 1 year
|
Optical coherence tomography
|
1 year
|
Tactile Sensation
Časové okno: 1 year
|
Von Frey sensory thresholds
|
1 year
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Mijail Serruya, MD, PhD, TJUH
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 14D.611
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