Development of Normative Datasets for Assessments Planned for Use in Patients With Mild Traumatic Brain Injury (NORMAL)
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.
Condition:
Focus: Healthy Adults Without Brain Injury
Treatment:
Start Date:
January 10, 2014
Sponsor:
Lindell Weaver
For More Information:
https://clinicaltrials.gov/show/NCT01925963