Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT03998358
Status:
WITHDRAWN
Last Update Posted:
2021-03-25
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries
Sponsor:
National Institute of Nursing Research (NINR)
Organization:
Study Overview
Official Title:
Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment method is no longer active.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Objective: Traumatic brain injury (TBI) is the signature injury of recent wars. Fatigue is a pervasive and debilitating consequence of TBIs, experienced by up to 80% of military personnel following TBI. If present greater than 6 months post-injury, fatigue is classified as chronic and may hinder recovery and affect return to service in military personnel. However, the pathophysiology through which TBI results in fatigue symptomology remains unclear. This protocol will examine several pathways that have been hypothesized to underlie the association between TBI and fatigue including; sleep disturbances, neuroendocrine and mitochondrial abnormalities. Sleep disturbances and fatigue overlap and frequently co-occur after TBI. However, to date no published studies have investigated the association between objectively measured sleep and fatigue following TBI with and without significant fatigue in military personnel. The second pathway involves dysfunction of the neuroendocrine system, which participates in the regulation of sleep states, circadian function, and attention. Deficits in neuroendocrine function, including putative changes in crucial neuronal populations in the hypothalamus and in somatotrophic cells of the anterior pituitary will result in changes in regulatory hormones such as growth hormone (GH). Evidence suggests that disruptions to GH may be associated with fatigue, however, current findings are mixed. The final pathway may be through mitochondrial dysfunction. Early results from multiple fields have shown that decreased mitochondrial markers have been associated with fatigue, however few studies have looked at these predicted associations in TBI populations. It is evident that further research is needed to examine the relationships between TBI and fatigue. Thus, this protocol aims to identify the pathways associated with TBI and fatigue. Findings from this protocol may lead to novel targets for intervention and reduction of fatigue symptomology following TBI.
Aim: To identify factors that are associated with the persistence of fatigue symptomology, at or greater than 6 months post TBI.
Protocol 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.
Design: We will compare military personnel who have sustained a TBI with and without subsequent fatigue symptomology. This protocol will have two visits, one outpatient and one inpatient to NIH which include:
Screening Visit: All participants will undergo a clinical evaluation of TBI history, fatigue, and complete self-report questionnaires. Participants will also be given an actigraph and sleep diary to take home and complete.
Sleep Visit: All participants will undergo two, consecutive, overnight polysomnography (PSG) tests, which includes one night of serial blood sampling to examine endocrine function and neuropeptide release. Over the two days, participants may also complete an optional hydrocortisone stimulation test and their mitochondrial respiratory profile will be assessed. During this in-patient stay, all participants will undergo neurocognitive testing and have an opportunity to undergo magnetic resonance imaging (MRI).
Aim: To identify factors that are associated with the persistence of fatigue symptomology, at or greater than 6 months post TBI.
Protocol 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.
Design: We will compare military personnel who have sustained a TBI with and without subsequent fatigue symptomology. This protocol will have two visits, one outpatient and one inpatient to NIH which include:
Screening Visit: All participants will undergo a clinical evaluation of TBI history, fatigue, and complete self-report questionnaires. Participants will also be given an actigraph and sleep diary to take home and complete.
Sleep Visit: All participants will undergo two, consecutive, overnight polysomnography (PSG) tests, which includes one night of serial blood sampling to examine endocrine function and neuropeptide release. Over the two days, participants may also complete an optional hydrocortisone stimulation test and their mitochondrial respiratory profile will be assessed. During this in-patient stay, all participants will undergo neurocognitive testing and have an opportunity to undergo magnetic resonance imaging (MRI).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 19-NR-0115 | None | None | View |