Service Member Fatigue and Lack of Motivation Following Concussion

NCT01496586 | Completed

• 2 other identifiers: 12003012-N-0030
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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....

Conditions

Fatigue; Traumatic Brain Injury

Keywords

Fatigue; Traumatic Brain Injury; Motivational Incentive; TBI

Outcome Measures

Primary 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 fatigue, apathy, effort expenditure.

  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

  One year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• Claustrophia;
• Inability to comfortably lie supine for two hours
• 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.
• Lack of understanding of the English language

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 18234750 BACKGROUND

• Jones 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.

  PMID: 17974926 BACKGROUND

• Jones 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.

  PMID: 11834557 BACKGROUND

MeSH Terms

Conditions

Fatigue; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2011
• First Posted: December 21, 2011
• Study Start: December 1, 2011
• Study Completion: August 3, 2015
• Last Updated: December 17, 2019

Record last verified: 2015-08-03

Locations

US (1)