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

6. august 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19112
        • Rekruttering
        • Jefferson Comprehensive Concussion Center
        • Kontakt:
          • Mijail Serruya, MD, PhD
          • Telefonnummer: 267-463-2300

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medical history indicative of concussion
Tidsramme: Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
Upon enrollment

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Mijail Serruya, MD, PhD, TJUH

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2015

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

25. marts 2015

Først indsendt, der opfyldte QC-kriterier

6. august 2015

Først opslået (Skøn)

11. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2015

Sidst verificeret

1. august 2015

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjernerystelse

Kliniske forsøg med Concussion

Abonner