- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19112
- Reclutamiento
- Jefferson Comprehensive Concussion Center
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Contacto:
- Mijail Serruya, MD, PhD
- Número de teléfono: 267-463-2300
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Medical history indicative of concussion
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year
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King Devick Test
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1 year
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Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year
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ImPACT
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1 year
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Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 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
Periodo de tiempo: 1 year
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Reverse Digit Span
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1 year
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Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year
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Fatigue Severity Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
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Epworth Sleepiness Scale
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1 year
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Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
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Pittsburgh Sleep Quality Index
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1 year
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Diagnostic Procedures
Periodo de tiempo: 1 year
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Galvanic skin response
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1 year
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Diagnostic Procedures
Periodo de tiempo: 1 year
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Electrocardiography (EKG)
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1 year
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Diagnostic Procedures
Periodo de tiempo: 1 year
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Electroencephalography (EEG)
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1 year
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Diagnostic Procedures
Periodo de tiempo: 1 year
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Fundoscopy Optical Coherence Tomography (OCT)
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1 year
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Diagnostic Procedures
Periodo de tiempo: 1 year
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Von Frey Sensory Filament Thresholds
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1 year
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Diagnostic Procedures
Periodo de tiempo: 1 year
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BioSway
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1 year
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Biospecimens
Periodo de tiempo: 1 year
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Blood
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1 year
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Biospecimens
Periodo de tiempo: 1 year
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Siliva
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1 year
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Biospecimens
Periodo de tiempo: 1 year
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Urine
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1 year
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Clinically Acquired Imaging
Periodo de tiempo: 1 year
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CT, MRI
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1 year
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Opthalmologic
Periodo de tiempo: 1 year
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Fundoscopic photographs
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1 year
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Opthalmologic
Periodo de tiempo: 1 year
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Optical coherence tomography
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1 year
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Tactile Sensation
Periodo de tiempo: 1 year
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Von Frey sensory thresholds
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1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mijail Serruya, MD, PhD, TJUH
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14D.611
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