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

6 de agosto de 2015 atualizado 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Antecipado)

1000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19112
        • Recrutamento
        • Jefferson Comprehensive Concussion Center
        • Contato:
          • Mijail Serruya, MD, PhD
          • Número de telefone: 267-463-2300

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

10 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Medical history indicative of concussion
Prazo: Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
Upon enrollment

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2015

Conclusão Primária (Antecipado)

1 de dezembro de 2016

Conclusão do estudo (Antecipado)

1 de dezembro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

25 de março de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de agosto de 2015

Primeira postagem (Estimativa)

11 de agosto de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

11 de agosto de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2015

Última verificação

1 de agosto de 2015

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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