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

6. August 2015 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

1000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19112
        • Rekrutierung
        • Jefferson Comprehensive Concussion Center
        • Kontakt:
          • Mijail Serruya, MD, PhD
          • Telefonnummer: 267-463-2300

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

10 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Medical history indicative of concussion
Zeitfenster: Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
Upon enrollment

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Mijail Serruya, MD, PhD, TJUH

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2015

Primärer Abschluss (Voraussichtlich)

1. Dezember 2016

Studienabschluss (Voraussichtlich)

1. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

25. März 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. August 2015

Zuerst gepostet (Schätzen)

11. August 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

11. August 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. August 2015

Zuletzt verifiziert

1. August 2015

Mehr Informationen

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