Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury
Condition: Traumatic Brain Injury; Parkinson's Disease
MeSH terms: Parkinson Disease; Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      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").
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Collect blood and extract and store plasma and DNA from 100 mTBI and 100 mTBI- subjects
      undergoing clinical assessments and DaTscan studies.
    
Keywords: TBI; PD