Normative Datasets for Assessments Planned for Mild Traumatic Brain Injury (NORMAL)

NCT01925963 | Completed

• 1 other identifier: S-11-16
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Focus: Healthy Adults Without Brain Injury

Keywords

Normal; Traumatic brain injury; Neuroimaging; Hyperbaric oxygen; Neurobehavioral symptom inventory

Outcome Measures

Primary Outcomes (1)

• Change in neuropsychological test scores across time

  Baseline and 13 weeks

Secondary Outcomes (7)

• 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

Study Arms (1)

Normal cohort

Normal, healthy adults without history of brain injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal, healthy, non-brain injured civilians and military participants (active or inactive)

You may qualify if:

• Active duty or civilian in the Colorado Springs area.
• Men 18-65 years old and women 18-35 years old at the time of enrollment.
• Able to speak and read English, as primary language.
• Agrees to, and appears able to participate in all outcome assessments.
• Agrees to provide blood samples for laboratory tests and specimen banking.
• Demonstrates the ability to offer informed consent and signs the study informed consent document.
• No known brain imaging abnormalities.
• Known history of full term non-complicated birth.
• Estimated glomerular filtration rate (eGFR) \>90.

You may not qualify if:

• Prisoners.
• Pregnant Women.
• Minors.
• Civilian participants with planned leave conflicting with study visits or relocation within 6 months of study enrollment, and unwilling or unable to return for follow up.
• Active duty participants with planned leave or deployment conflicting with assessment intervals.
• Any lifetime history of brain injury.
• Diagnosis of, or a persistent history of, or symptoms of a neurological disorder (e.g., tinnitus, vertigo, chronic fatigue, numbness, tingling, chronic migraine, fibromyalgia, multiple sclerosis).
• Active therapy for affective disorders, behavioral disorders, or psychological disorders.
• Diagnosis of diabetes mellitus
• Current complaints of brain injury symptoms such as cognitive or affective problems.
• Diagnosis of recurrent migraine or cluster headaches that are under medical management.
• Headaches that occur more than two times per week.
• Recurrent dizziness that requires medical management.
• Dizziness more than two times per week.
• History of theater or war zone activity that placed the participant within a combat zone environment.

Sponsors & Collaborators

• Lindell Weaver: lead
• U.S. Army Medical Research and Development Command: collaborator
• The Emmes Company, LLC: collaborator
• Intermountain Health Care, Inc.: collaborator
• Evans Army Community Hospital: collaborator

Study Sites (2)

Outcomes Assessment Center

Colorado Springs, Colorado, 80906, United States

Location

Evans Army Community Hospital

Colorado Springs, Colorado, 80913, United States

Location

Related Publications (6)

• 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.

  PMID: 22908837 BACKGROUND

• 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.

  PMID: 31394600 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.

  PMID: 31394594 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.

  PMID: 30631299 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.

  PMID: 30099354 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.

  PMID: 30098189 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Robert C Price, MD

  Evans Army Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: January 10, 2014
• Primary Completion: January 6, 2016
• Study Completion: January 6, 2016
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (2)