Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries

NCT03998358 | Withdrawn

• 2 other identifiers: 19011519-NR-0115
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Neurobehavioral Manifestation; Sleep Disorder; Fatigue

Keywords

Circadian Rhythm; Biomarkers; Neuroendocrine; Sleep; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Determine differences in objective sleep measures determined by actigraphy and PSG data in military personnel with and without fatigue following a TBI.

  The PSG will be scored by the Clinical Center Sleep Service within two weeks and will generate the following data: -Sleep Onset Latency (SOL): Is a measurement of the time taken to fall asleep from the time the lights were turned off. On average, this process takes approximately 20 minutes. - Sleep efficiency (SE): the number of minutes of sleep divided by the number of minutes in bed. Normal is approximately 85 to 90% or higher, but in-lab values are often less. -Sleep stages; From this information each 30-second epoch is scored as "awake" or one of 4 sleep stages: 1, 2, 3, and REM or Rapid Eye Movement sleep. Stages 1-3 are together called non-REM sleep. Non-REM sleep is distinguished from REM sleep, which is altogether different. Delta power for each stage will also be examined. The primary outcome being assessed will be delta power of SWS and REM between fatigued and non-fatigued.

  Study completion

Secondary Outcomes (7)

• Determine differences in neurobehavioral and neurocognitive functioning in military personnel with and without fatigue following a TBI.

  Study Completion

• Describe differences in plasma concentration levels of neuroendocrine proteins during overnight hours in military personnel with and without fatigue following a TBI.

  Study Completion

• Determine differences in neuroendocrine and mitochondrial functionality in military personnel with and without fatigue following a TBI.

  Study Completion

• Compare group differences in level of fatigue between the two protocol visits.

  Study Completion

• Determine differences in perceived sleep quality (PSQI) and actual sleep quality as measured by actigraphy.

  Study Completion

Study Arms (2)

High Fatigue

TBI patients with significant fatigue as calculated by a score of \>= 5.5 on the Fatigue Severity Scale

Low Fatigue

TBI patients without significant fatigue as calculated by a score of \< 5.5 on the Fatigue Severity Scale

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Up to 74 military personnel will be recruited into this protocol. All participants will have experienced their most recent TBI \>= 6 months and \<= 5 years prior to protocol participation.@@@@@@

You may qualify if:

• Are 25 to 40 years of age
• Are active duty service members or veterans
• May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff
• Have sustained at least 1 TBI, \>= 6 months and \<= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call
• Are able to provide their own consent
• Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz

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)

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and PBMCs

MeSH Terms

Conditions

Brain Injuries, Traumatic; Neurobehavioral Manifestations; Sleep Wake Disorders; Fatigue

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jessica Gill, Ph.D.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 26, 2019
• Study Start: March 19, 2021
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

US (1)