Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries

Withdrawn before enrolling

Conditions studied: Traumatic Brain Injury, Neurobehavioral Manifestation, Sleep Disorder, Fatigue

In brief

Background: People who have had a traumatic brain injury (TBI) often experience fatigue. Fatigue is the feeling tired all the time. Researchers want to learn more about how TBI and fatigue are related. Objective: To better understand fatigue after TBI in active duty military and veterans. Eligibility: Active duty service members or veterans ages 25-40 who have sustained at least 1 TBI more than 6 months but less than 5 years ago Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests Participants will have Visit 1 the same day as screening. This will include questionnaires and interviews. These will be about their fatigue, quality of life, and health. Participants will wear an activity monitor on their wrist and complete a sleep diary for 7 days at home. Participants will have Visit 2: They will stay in the clinic for 2 nights. The visit will include: * Tests of memory, attention, and thinking * Placement of intravenous (IV) line: A needle will guide a thin plastic tube into the participant s arm vein. * 2 overnight sleeps tests: Participants brain waves will be recorded while they sleep. Small electrodes will be placed on the scalp. Monitors will be placed on the skin. These will measure breathing, heart rate, and movement. Blood will be drawn overnight through the IV line. * Optional hydrocortisone stimulation test: Participants will receive the hormone through the IV line. Blood will be drawn through the IV line 5 times over 1 hour. * Optional MRI: Participants will lie in a machine. This machine is a metal cylinder that takes pictures of the brain.

Key facts

Study ID: NCT03998358
Run by: National Institute of Nursing Research (NINR)
People needed: 0
Starts: 2021-03-19
Expected to finish: 2021-03-19
Last updated by the study team: 2021-03-25

Who can join

Age: 25 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included.
Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests.
Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests.
Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report.
Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report.
Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report.
Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam.
Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test.
Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report.
*Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following:
Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker
Claustrophobia
Are not able to lie comfortably flat on their back for up to 60 minutes
*Participant may be able to participate in the protocol but will not be able to have the hydrocortisone stimulation test if they have any of the following:
History of endocrine disorder or dysfunction (including thyroid, adrenal, pancreatic and pituitary disorders)
Abnormal lab values that may indicate endocrine disorder or dysfunction
Mother who is currently nursing an infant

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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