Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

6 augusti 2015 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

1000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19112
        • Rekrytering
        • Jefferson Comprehensive Concussion Center
        • Kontakt:
          • Mijail Serruya, MD, PhD
          • Telefonnummer: 267-463-2300

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

10 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Medical history indicative of concussion
Tidsram: Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
Upon enrollment

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Mijail Serruya, MD, PhD, TJUH

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2015

Primärt slutförande (Förväntat)

1 december 2016

Avslutad studie (Förväntat)

1 december 2016

Studieregistreringsdatum

Först inskickad

25 mars 2015

Först inskickad som uppfyllde QC-kriterierna

6 augusti 2015

Första postat (Uppskatta)

11 augusti 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 augusti 2015

Senast verifierad

1 augusti 2015

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Hjärnskakning

Kliniska prövningar på Concussion

3
Prenumerera