FatigueNCT01496586
Service Member Fatigue and Lack of Motivation Following Concussion
An observational study of Fatigue and Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Traumatic Brain Injury
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2011to 3 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of at least one mTBI during deployment;
- At least six months from time of injury;
- Age range 18 or older;
- A self-report of somatic or behavioral symptoms that developed within 3 months following mTBI and were not present before injury, and may or may not be present at enrollment:
- Easy fatiguability
- Sleep disturbance
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- Headache or other chronic widespread pain that does not seem related to extremity injury
- Emotional lability
- Lack of spontaneity or apathy
- Lack of motivation
- Feelings of anxiety
- Personality change that they or others have noticed
- Irritability or aggressiveness
- The mTBI participant provides informed consent.
- Chosen by a mTBI participant as a close companion (i.e, spends or in the last 3 years has spent a minimum of 1 hour per week on average with the mTBI participant and with whom the mTBI participant is comfortable discussing personal matters);
- The companion provides informed consent.
Who cannot join
- Daily use of stimulants, narcotics, hypnotic or anxiolytics
- Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis
- Any history of head injury associated with a loss of consciousness that lasted longer than 24 hours (not including sedation);
- Daily use of more than 600mg caffeine (equivalent to approximately five cups of coffee).
- Headaches more than once a month prior to deployment;
- Pregnancy;
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- Claustrophia;
- Inability to comfortably lie supine for two hours
- -Lack of understanding of the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Fatigue and Amotivation Following Mild Traumatic Brain Injury and Their Influence on Service Member Community Reintegration
Background:
- Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion.
Read more
Objectives:
- To learn more about the problems that may occur after service members have a concussion during deployment and return home.
Eligibility:
- Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months.
- Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment.
Design:
- Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center.
- Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity.
- Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support....
Read the detailed description
Objective: The primary objective of this study is to determine the behavioral-anatomical relationships that underlie fatigue and amotivation following mild traumatic brain injury in deployed military service members. The specific aims are to 1) determine the neural correlates of fatigue, and 2) assess how fatigue and social cognition relate to social outcomes including employment, community integration and participation in social activities. The theory we will test is that fatigue in this population is the result of subtle changes in frontal cortical and subcortical structures.
Study Design: Observational, natural history study.
Populations: 1) Individuals who have sustained a mild traumatic brain injury as a service member deployed in support of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn, and who continue to experience symptoms more than 6 months after injury, and 2) Companions of individuals from the first group.
Outcome Measures: We will seek statistical associations between fatigue measures and brain morphometric and white matter diffusion measurements obtained by MRI as well as task and resting state fMRI.
- Conditions
- Fatigue, Traumatic Brain Injury
- Keywords
- Fatigue, Traumatic Brain Injury, Motivational Incentive, TBI
- Medical subject headings
- Fatigue, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of fatigue, apathy, effort expenditure.
Measured: One year
Secondary outcomes (1)
Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of alexithymia and perceived stress
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study start1 Dec 2011
- Study completion3 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496586
- Sponsor's protocol ID
- 120030
- Other IDs
- 12-N-0030
- Status last verified
- 3 Aug 2015
- First submitted
- 17 Dec 2011
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.
PubMed 18234750Jones E, Fear NT, Wessely S. Shell shock and mild traumatic brain injury: a historical review. Am J Psychiatry. 2007 Nov;164(11):1641-5. doi: 10.1176/appi.ajp.2007.07071180.
PubMed 17974926Jones E, Hodgins-Vermaas R, McCartney H, Everitt B, Beech C, Poynter D, Palmer I, Hyams K, Wessely S. Post-combat syndromes from the Boer war to the Gulf war: a cluster analysis of their nature and attribution. BMJ. 2002 Feb 9;324(7333):321-4. doi: 10.1136/bmj.324.7333.321.
PubMed 11834557
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and Amotivation Following Mild Traumatic Brain Injury and Their Influence on Service Member Community Reintegration
- ClinicalTrials.gov ID
- NCT01496586
- Acronym / sponsor ID
- 120030
- Conditions
- Fatigue, Traumatic Brain Injury
- Keywords
- Fatigue, Traumatic Brain Injury, Motivational Incentive, TBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Dec 2011
- Study completion
- 3 Aug 2015
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion.
Objectives:
- To learn more about the problems that may occur after service members have a concussion during deployment and return home.
Eligibility:
- Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months.
- Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment.
Design:
- Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center.
- Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity.
- Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support....
Detailed description
Objective: The primary objective of this study is to determine the behavioral-anatomical relationships that underlie fatigue and amotivation following mild traumatic brain injury in deployed military service members. The specific aims are to 1) determine the neural correlates of fatigue, and 2) assess how fatigue and social cognition relate to social outcomes including employment, community integration and participation in social activities. The theory we will test is that fatigue in this population is the result of subtle changes in frontal cortical and subcortical structures.
Study Design: Observational, natural history study.
Populations: 1) Individuals who have sustained a mild traumatic brain injury as a service member deployed in support of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn, and who continue to experience symptoms more than 6 months after injury, and 2) Companions of individuals from the first group.
Outcome Measures: We will seek statistical associations between fatigue measures and brain morphometric and white matter diffusion measurements obtained by MRI as well as task and resting state fMRI.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of at least one mTBI during deployment;
- At least six months from time of injury;
- Age range 18 or older;
- A self-report of somatic or behavioral symptoms that developed within 3 months following mTBI and were not present before injury, and may or may not be present at enrollment:
- The mTBI participant provides informed consent.
Key exclusion criteria (9 listed)
- Daily use of stimulants, narcotics, hypnotic or anxiolytics
- Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis
- Any history of head injury associated with a loss of consciousness that lasted longer than 24 hours (not including sedation);
- Daily use of more than 600mg caffeine (equivalent to approximately five cups of coffee).
- Headaches more than once a month prior to deployment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of fatigue, apathy, effort expenditure.
Time frame: One year
1 secondary outcome
Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of alexithymia and perceived stress
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 18234750Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008 Jan 31;358(5):453-63. doi: 10.1056/NEJMoa072972. Epub 2008 Jan 30.
- Background: PubMed 17974926Jones E, Fear NT, Wessely S. Shell shock and mild traumatic brain injury: a historical review. Am J Psychiatry. 2007 Nov;164(11):1641-5. doi: 10.1176/appi.ajp.2007.07071180.
- Background: PubMed 11834557Jones E, Hodgins-Vermaas R, McCartney H, Everitt B, Beech C, Poynter D, Palmer I, Hyams K, Wessely S. Post-combat syndromes from the Boer war to the Gulf war: a cluster analysis of their nature and attribution. BMJ. 2002 Feb 9;324(7333):321-4. doi: 10.1136/bmj.324.7333.321.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of fatigue, apathy, effort expenditure. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01496586, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.