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

Completed

Conditions studied: Focus: Healthy Adults Without Brain Injury

In brief

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.

Key facts

Study ID

NCT01925963

Run by

Lindell Weaver

People needed

83

Starts

2014-01-10

Expected to finish

2016-01-06

Last updated by the study team

2018-08-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• Diagnosis of PTSD or sub-clinical post-traumatic symptoms.
• Known neuroimaging abnormalities.
• Use of daily prescription drugs that could impact a normal outcome (e.g., beta blockers, antidepressants), with the following exceptions:
• Participants who are 45 or more years old may be taking statins or ACE inhibitors.
• Oral or injectable contraceptives are permitted
• Participants <45 years old who are taking any daily prescriptions (exception - oral or injectable contraceptives)
• Known atrial septal defect.
• History of hydrocephalus/microcephaly/macrocephaly.
• History of developmental delay or learning disorder as a child.
• Women who are breastfeeding.

Where it is running

• Outcomes Assessment Center — Colorado Springs, Colorado, United States
• Evans Army Community Hospital — Colorado Springs, Colorado, United States

Full record on ClinicalTrials.gov

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