Normative Datasets for Assessments Planned for Mild Traumatic Brain Injury (NORMAL) (NORMAL)
|ClinicalTrials.gov Identifier: NCT01925963|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : December 20, 2016
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.
|Condition or disease|
|Focus: Healthy Adults Without Brain Injury|
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.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Development of Normative Datasets for Assessments Planned for Use in Patients With Mild Traumatic Brain Injury (NORMAL)|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2017|
Normal, healthy adults without history of brain injury
- Change in neuropsychological test scores across time [ Time Frame: Baseline and 13 weeks ]
- Change in neuropsychological test scores across time [ Time Frame: Baseline and 6 months ]
- Change in cerebral blood flow by computed tomography angiography [ Time Frame: Baseline and 6 months ]
- Change in brain anatomical structures by quantitative magnetic resonance imaging [ Time Frame: Baseline and 6 months ]
- Change in brain activation by functional magnetic resonance imaging [ Time Frame: Baseline and 6 months ]
- Change in visual refractive error [ Time Frame: Baseline and 13 weeks ]
- Change in visual refractive error [ Time Frame: Baseline and 6 months ]
- Change in sleep quality total score by Pittsburgh Sleep Quality Index [ Time Frame: Baseline and 13 weeks ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925963
|United States, Colorado|
|Outcomes Assessment Center|
|Colorado Springs, Colorado, United States, 80906|
|Evans Army Community Hospital|
|Colorado Springs, Colorado, United States, 80913|
|Principal Investigator:||Robert C Price, MD||Evans Army Community Hospital|