Fatigue Clinical Trial
Official title:
Post-TBI Fatigue and Its Treatment
Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.
Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a
treatment for fatigue post TBI.
Background: After TBI, fatigue is one of the most common complaints, as documented in our
work and that of many other researchers. People with TBI experience fatigue that seems to
them out of proportion to whatever work they are doing or effort they are making. Fatigue
after TBI is associated with decreased participation in normal activities in the community
and has been linked to depression.
Need for Research: Research on use of drugs to treat post-TBI fatigue is inadequate. While
studies of fatigue in people with other chronic conditions suggest that modafinil helps
relieve fatigue and has fewer side effects than some other drugs used in treating fatigue,
the use of modafinil has not yet been tested in people with TBI.
Current and Future Research Activity: More than 100 men and women volunteers who complain of
post-TBI fatigue will be randomly assigned to a 4-week period of taking modafinil or a
placebo. At the beginning and end of the study, the severity of their fatigue and associated
symptoms (e.g., cognitive function, mood, pain, daytime sleepiness, sleep quality, health
status) will be assessed, as well as their participation in activities and perceived quality
of life. It is hypothesized that modafinil will reduce the symptoms of fatigue and will
increase level of activity and perceived quality of life to a significantly greater extent
than will the placebo.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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