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Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury

19. juli 2019 oppdatert av: NorthShore University HealthSystem

Imaging Biomarkers of Delayed Sequelae in Mild to Moderate Traumatic Brain Injury

The purpose of this study is to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a possible association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122 subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University HealthSystem during the years 2006-2011, and to select from willing eligible subjects a random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to undergo written informed consent, neurological examinations, blood drawing for DNA extraction and storage, and DaTscan brain imaging. The investigators will compare the findings from persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or "controls").

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This study is being done to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain ("biomarkers") that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a potential link between mild to moderate traumatic brain injury (mTBI) and PD. We will compare findings from persons who experienced mTBI ("cases") to persons without history of brain injury (mTBI-or "controls"). This study may provide preliminary data that might be used to help design future long-term studies.

The investigators propose scientific studies with one specific aim and two hypotheses:

Specific aim: to determine if one year post emergency room (ER) visits, DaTscan uptake (Ioflupane I123 injection and single photon emission computerized tomography) is lower in subjects exposed to mTBI (defined as a closed head trauma that results in loss of consciousness or amnesia for less than 24 hours) than in subjects not exposed to mTBI (without closed head trauma; mTBI-).

Hypotheses:

Hypothesis #1: mTBI is a risk factor for Parkinson's disease (PD). Hypothesis #2: DaTscan is able to detect subclinical PD (as measured by a dopamine transporter deficiency) in mTBI subjects.

Studietype

Observasjonsmessig

Registrering (Faktiske)

67

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Evanston, Illinois, Forente stater, 60201
        • Northshore University Healthsystem

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

A historical cohort of 7,122 mTBI cases and 7,122 age and gender matched mTBI- controls was defined from the electronic medical records of NorthShore University HealthSystem. From survey respondents we are randomly selecting 100 mTBI cases and 100 age and gender matched mTBI- controls to undergo neurological examinations and DaTscan studies.

Beskrivelse

Inclusion Criteria:

  • mTBI or mTBI- survey respondents
  • Ages 18-100 years
  • Without a history of parkinsonism or tremor

Exclusion Criteria:

  • History of parkinsonism or tremor
  • Lugol or iodide allergy
  • Contraindicated medications for DaTscan
  • Pregnancy or nursing mothers
  • Renal or liver impairment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
mTBI
Historical cohort of subjects seen in the emergency rooms of NorthShore University HealthSystem with ICD-9 diagnoses of mild or moderate traumatic brain injury during the years 2006-2011 (7,122 subjects). 100 mTBI+ subjects are randomly selected for clinical assessment and DaTscan.
mTBI-
Historical cohort of subjects seen in the emergency rooms of NorthShore University HealthSystem with ICD-9 diagnoses of disorders other than mild or moderate traumatic brain injury during the years 2006-2011 (7,122 subjects). 100 mTBI- subjects are randomly selected for clinical assessment and DaTscan.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
DaTSCAN
Tidsramme: At least one year post ER visit for mTBI or mTBI-
We will perform qualitative (visual) and quantitative (DaTQUANT) analyses of striatal uptake.
At least one year post ER visit for mTBI or mTBI-

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
clinical assessment
Tidsramme: At least one year post ER visit for mTBI or mTBI-
All subjects complete a questionnaire that documents lifelong exposures to mTBI; that screens for parkinsonism, Parkinson's disease, or tremor; and that screens for DaTSCAN exclusion criteria. We abstract medical records. Subjects eligible for DaTSCAN undergo the Montreal Cognitive Assessment (MoCA); Ohio State University TBI Identification Method Short Form (OSU-TBI-ID-SF); General Anxiety Disorder 7-item Scale (GAD7); Center for Epidemiological Studies Depression Scale (CES-D); Rivermead Post Concussion Symptoms Questionnaire; Insomnia Severity Index (ISI); World Health Organization Quality of Life-Brief Assessment (WHOQOL-BREF); Review of Systems; Past Medical History; Detailed Examination of Motor Function-Unified Parkinson's Disease Rating Scale (UPDRS part III); Neurological Examination; Syndromic Classification (parkinsonism, essential tremor, mild cognitive impairment); Differential Diagnosis of Parkinsonism (if applicable); Final Diagnosis of Parkinsonism (if applicable).
At least one year post ER visit for mTBI or mTBI-

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NorthShore University HealthSystem

Samarbeidspartnere

GE Healthcare

Etterforskere

  • Hovedetterforsker: Demetrius M Maraganore, MD, Northshore University Healthsystem

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2012

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

19. januar 2012

Først innsendt som oppfylte QC-kriteriene

23. januar 2012

Først lagt ut (Anslag)

24. januar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juli 2019

Sist bekreftet

1. januar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EH11-345

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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