NORMAL
Development of Normative Datasets for Assessments Planned for Use in Patients With Mild Traumatic Brain Injury (NORMAL)
Sponsor study identifier
observational
83
1 country
2
Study Start
January 10, 2014
Actual (reported)Primary Completion
January 6, 2016
Actual (reported)Study Completion
January 6, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 6, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 16, 2013
Actual (reported)August 20, 2013
Actual (reported)January 10, 2014
Actual (reported)January 6, 2016
Actual (reported)January 6, 2016
Actual (reported)Change in neuropsychological test scores across time
Baseline and 13 weeks
Change in neuropsychological test scores across time
Baseline and 6 months
Change in cerebral blood flow by computed tomography angiography
Baseline and 6 months
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
Normal, healthy adults without history of brain injury
Normal, healthy, non-brain injured civilians and military participants (active or inactive)
Outcomes Assessment Center
Colorado Springs, Colorado, 80906, United States
Evans Army Community Hospital
Colorado Springs, Colorado, 80913, United States
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.
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.
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.
Robert C Price, MD
Evans Army Community Hospital
83 participants (actual enrollment reported by the registry).
First Submitted
August 16, 2013
First Posted
August 20, 2013
Study Start
January 10, 2014
Actual (reported)Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
January 6, 2016
Actual (reported)Study Completion
January 6, 2016
Actual (reported)Last Updated
August 27, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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