Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development

6 de agosto de 2015 actualizado por: Thomas Jefferson University
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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

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

De observación

Inscripción (Anticipado)

1000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19112
        • Reclutamiento
        • Jefferson Comprehensive Concussion Center
        • Contacto:
          • Mijail Serruya, MD, PhD
          • Número de teléfono: 267-463-2300

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

10 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Individuals ages 10 or older. If the patient has experienced a suspected concussion, must be a patient at the Jefferson Comprehensive Concussion Center.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medical history indicative of concussion
Periodo de tiempo: Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
Upon enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Sports Concussion Assessment Tool (SCAT-3)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Balance Error Scoring System (BESS)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
King Devick Test
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Acute Concussion Evaluation (ACE)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Beck Depression Inventory (BDI)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Beck Anxiety Inventory (BAI)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
World Health Organization-Five Well-being Index (WHO-5)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Multidimensional Anxiety Scale for Children (MASC)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Spence Children's Anxiety Scale
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
"SCARED" Montgomery-Åsberg Depression Rating Scale
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
ImPACT
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Trails A and B Forward
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Reverse Digit Span
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Jefferson After Concussion Test (JACT)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Rivermead Post Concussion Symptom Questionnaire (RPQ)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Traumatic Brain Injury-Quality of Life (TBI-QOL)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Mayo-Portland Adaptability Inventory (MPAI-4)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Migraine Disability Assessment (MIDAS)
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Fatigue Severity Scale
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Epworth Sleepiness Scale
1 year
Neurocognitive Testing and Assessment Batteries
Periodo de tiempo: 1 year
Pittsburgh Sleep Quality Index
1 year
Diagnostic Procedures
Periodo de tiempo: 1 year
Galvanic skin response
1 year
Diagnostic Procedures
Periodo de tiempo: 1 year
Electrocardiography (EKG)
1 year
Diagnostic Procedures
Periodo de tiempo: 1 year
Electroencephalography (EEG)
1 year
Diagnostic Procedures
Periodo de tiempo: 1 year
Fundoscopy Optical Coherence Tomography (OCT)
1 year
Diagnostic Procedures
Periodo de tiempo: 1 year
Von Frey Sensory Filament Thresholds
1 year
Diagnostic Procedures
Periodo de tiempo: 1 year
BioSway
1 year
Biospecimens
Periodo de tiempo: 1 year
Blood
1 year
Biospecimens
Periodo de tiempo: 1 year
Siliva
1 year
Biospecimens
Periodo de tiempo: 1 year
Urine
1 year
Clinically Acquired Imaging
Periodo de tiempo: 1 year
CT, MRI
1 year
Opthalmologic
Periodo de tiempo: 1 year
Fundoscopic photographs
1 year
Opthalmologic
Periodo de tiempo: 1 year
Optical coherence tomography
1 year
Tactile Sensation
Periodo de tiempo: 1 year
Von Frey sensory thresholds
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Mijail Serruya, MD, PhD, TJUH

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2015

Finalización primaria (Anticipado)

1 de diciembre de 2016

Finalización del estudio (Anticipado)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

25 de marzo de 2015

Primero enviado que cumplió con los criterios de control de calidad

6 de agosto de 2015

Publicado por primera vez (Estimar)

11 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de agosto de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2015

Última verificación

1 de agosto de 2015

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Contusión cerebral

Ensayos clínicos sobre Concussion

3
Suscribir