- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
Обзор исследования
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Соединенные Штаты, 19112
- Рекрутинг
- Jefferson Comprehensive Concussion Center
-
Контакт:
- Mijail Serruya, MD, PhD
- Номер телефона: 267-463-2300
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
---|---|
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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Medical history indicative of concussion
Временное ограничение: Upon enrollment
|
Basic medical history demographics gathered during patient's regular clincal visit.
|
Upon enrollment
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Sports Concussion Assessment Tool (SCAT-3)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Balance Error Scoring System (BESS)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
King Devick Test
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Acute Concussion Evaluation (ACE)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Beck Depression Inventory (BDI)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Beck Anxiety Inventory (BAI)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
World Health Organization-Five Well-being Index (WHO-5)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Multidimensional Anxiety Scale for Children (MASC)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Spence Children's Anxiety Scale
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
"SCARED" Montgomery-Åsberg Depression Rating Scale
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
ImPACT
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Trails A and B Forward
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Reverse Digit Span
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Jefferson After Concussion Test (JACT)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Rivermead Post Concussion Symptom Questionnaire (RPQ)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Traumatic Brain Injury-Quality of Life (TBI-QOL)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Mayo-Portland Adaptability Inventory (MPAI-4)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Migraine Disability Assessment (MIDAS)
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Fatigue Severity Scale
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Epworth Sleepiness Scale
|
1 year
|
Neurocognitive Testing and Assessment Batteries
Временное ограничение: 1 year
|
Pittsburgh Sleep Quality Index
|
1 year
|
Diagnostic Procedures
Временное ограничение: 1 year
|
Galvanic skin response
|
1 year
|
Diagnostic Procedures
Временное ограничение: 1 year
|
Electrocardiography (EKG)
|
1 year
|
Diagnostic Procedures
Временное ограничение: 1 year
|
Electroencephalography (EEG)
|
1 year
|
Diagnostic Procedures
Временное ограничение: 1 year
|
Fundoscopy Optical Coherence Tomography (OCT)
|
1 year
|
Diagnostic Procedures
Временное ограничение: 1 year
|
Von Frey Sensory Filament Thresholds
|
1 year
|
Diagnostic Procedures
Временное ограничение: 1 year
|
BioSway
|
1 year
|
Biospecimens
Временное ограничение: 1 year
|
Blood
|
1 year
|
Biospecimens
Временное ограничение: 1 year
|
Siliva
|
1 year
|
Biospecimens
Временное ограничение: 1 year
|
Urine
|
1 year
|
Clinically Acquired Imaging
Временное ограничение: 1 year
|
CT, MRI
|
1 year
|
Opthalmologic
Временное ограничение: 1 year
|
Fundoscopic photographs
|
1 year
|
Opthalmologic
Временное ограничение: 1 year
|
Optical coherence tomography
|
1 year
|
Tactile Sensation
Временное ограничение: 1 year
|
Von Frey sensory thresholds
|
1 year
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Mijail Serruya, MD, PhD, TJUH
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 14D.611
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Concussion
-
VA Office of Research and DevelopmentЗавершенный