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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
| The Emmes Company, LLC | INDUSTRY |
| Intermountain Health Care, Inc. | OTHER |
| Evans Army Community Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal cohort | Normal, healthy adults without history of brain injury |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in neuropsychological test scores across time | Baseline and 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neuropsychological test scores across time | Baseline and 6 months | |
| Change in cerebral blood flow by computed tomography angiography | Baseline and 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Normal, healthy, non-brain injured civilians and military participants (active or inactive)
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Price, MD | Evans Army Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outcomes Assessment Center | Colorado Springs | Colorado | 80906 | United States | ||
| Evans Army Community Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22908837 | Background | Weaver LK, Cifu D, Hart B, Wolf G, Miller S. Hyperbaric oxygen for post-concussion syndrome: design of Department of Defense clinical trials. Undersea Hyperb Med. 2012 Jul-Aug;39(4):807-14. | |
| 31394600 | Derived | Wetzel PA, Lindblad AS, Mulatya C, Kannan MA, Villmar Z, Gitchel GT, Weaver LK. Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):299-311. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
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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.
| Change in brain anatomical structures by quantitative magnetic resonance imaging |
| Baseline and 6 months |
| Change in brain activation by functional magnetic resonance imaging | Baseline and 6 months |
| Change in visual refractive error | Baseline and 13 weeks |
| Change in visual refractive error | Baseline and 6 months |
| Change in sleep quality total score by Pittsburgh Sleep Quality Index | Baseline and 13 weeks |
| Colorado Springs |
| Colorado |
| 80913 |
| United States |
| 31394594 | Derived | Meehan A, Lewandowski A, Deru K, Hebert D, Weaver LK. Reference ranges and stability of auditory and vestibular measures in a comprehensive assessment battery for traumatic brain injury. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):227-241. |
| 30631299 | Derived | Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price R, Williams CS, Orrison WW, Patel JB, Walker JM, Meehan A, Mirow S; NORMAL Study Team. Comprehensive Evaluation of Healthy Volunteers Using Multi-Modality Brain Injury Assessments: An Exploratory, Observational Study. Front Neurol. 2018 Dec 17;9:1030. doi: 10.3389/fneur.2018.01030. eCollection 2018. |
| 30099354 | Derived | Walker JM, Mulatya C, Hebert D, Wilson SH, Lindblad AS, Weaver LK. Sleep assessment in a randomized trial of hyperbaric oxygen in U.S. service members with post concussive mild traumatic brain injury compared to normal controls. Sleep Med. 2018 Nov;51:66-79. doi: 10.1016/j.sleep.2018.06.006. Epub 2018 Jun 30. |
| 30098189 | Derived | Wetzel PA, Lindblad AS, Raizada H, James N, Mulatya C, Kannan MA, Villamar Z, Gitchel GT, Weaver LK. Eye Tracking Results in Postconcussive Syndrome Versus Normative Participants. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):4011-4019. doi: 10.1167/iovs.18-23815. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |