Focus: Healthy Adults Without Brain Injury Clinical Trial
Official title:
Development of Normative Datasets for Assessments Planned for Use in Patients With Mild Traumatic Brain Injury (NORMAL)
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.
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.
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