Normative Datasets for Assessments Planned for Mild Traumatic Brain Injury (NORMAL)
Condition: Focus: Healthy Adults Without Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of the research study is to collect information about brain function and
      structure among active duty military personnel or civilians who are healthy. Researchers want
      to develop a database from normal volunteers that will be used in comparison with a similar
      database from active duty military with post-concussive syndrome (PCS) from a mild traumatic
      brain injury. Findings from this study may be used to design larger studies that will
      evaluate whether hyperbaric oxygen treatments actually improve PCS.

      Participants in this study will undergo numerous tests to assess physical, mental, and
      intellectual health and how they might change over time. Participants will wear heart and
      activity monitors, undergo brain imaging, provide blood and urine for laboratory testing, and
      have vision, hearing, balance, and muscle function tests. They will also complete a number of
      questionnaires and interviews. This battery of tests will be repeated twice more over the
      course of 6 months.
    

Detailed description: 
      The primary purpose of this study will develop a database from normal healthy participants
      for the same outcomes used in a program of studies of hyperbaric oxygen (HBO2) vs. sham
      control in participants with persistent post-concussive symptoms. This study will
      characterize the distribution of responses and change in responses over time for each of the
      outcomes and will examine associations between measures within a given normal participant and
      across participant characteristics such as age and gender. It will evaluate the test-retest
      reliability of a series of assessments anticipated for use in the primary, secondary, and
      exploratory outcomes of this program of studies.

      A secondary purpose of this study is to compare normative values to results from randomized
      exploratory studies of HBO2 vs. sham control in participants with persistent post-concussive
      symptoms. Also, investigators will examine relationships between outcome measures from normal
      participants (with respect to clinical equivalence, participant burden, and risk) and compare
      to associations observed in other studies.

      In this study, normal, healthy, non-brain injured civilians and military participants (active
      or inactive) will undergo a battery of outcome assessments at defined test intervals to
      replicate the assessment battery used in a program of studies investigating the safety of
      HBO2 in patients with post-concussive symptoms following mild traumatic brain injury (TBI).

      The planned comprehensive assessments will obtain robust neuropsychological, physiological,
      and neuroimaging data. Other evaluations will include laboratory testing and evaluations of
      the auditory, vestibular, and visual systems. Neuroimaging (magnetic resonance imaging and
      computed tomography angiography) will be assessed in participants at baseline and 6 months.
      Neurological function and electroencephalography (EEG) will be assessed at baseline only. All
      other in-person outcome measures will be assessed in participants at baseline, at 13 weeks,
      and 6 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal, healthy, non-brain injured civilians and military participants (active or inactive)
      
Biospecimen description: 
      Serum and plasma will be collected and frozen for future analyses. Future work may examine
      DNA, chronic neuro-response biomarkers, plasma- and leukocyte-based markers of TBI using a
      number of modern molecular techniques to examine the expression profiles of genes, proteins,
      and other macromolecules and to correlate these profiles to clinical outcomes, and genotypes.
    
Keywords: Normal; Traumatic brain injury; Neuroimaging; Hyperbaric oxygen; Neurobehavioral symptom inventory