Fatigue Clinical Trial
Official title:
Modafinil for the Treatment of Fatigue and Excessive Daytime Sleepiness in Individuals With Traumatic Brain Injury
The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.
Background: An estimated 5.3 million Americans are living with a TBI-related disability
today. These persons may face many issues, however, two chronic problems seem common to a
strikingly large number of those who survive TBI: fatigue and EDS.
Need for Research: Modafinil has been shown to be useful for fatigue and sleepiness in
patients with depression, multiple sclerosis, Parkinson's disease and individuals with EDS
secondary to a variety of sleep disturbances. However, there has not been any controlled
evaluation of Modafinil use for the treatment of individuals with TBI to date.
Current and Future Research Activity: Approximately 60 participants with post-TBI fatigue
will be randomly assigned to two 10-week periods of taking either Modafinil or placebo.
Participants taking Modafinil during the first 10 weeks will be switched to placebo for the
second 10 weeks. Similarly, participants taking placebo during the first 10 weeks will be
switched to Modafinil for the second 10 weeks. Outcomes relating to fatigue and EDS will be
collected weekly throughout the study. Other outcomes (including general health, depression,
and cognitive function) will be collected at the start of each period, 4 weeks into each
period, and again at the end of each period. It is hypothesized that participants taking
Modafinil will report significantly less fatigue and EDS, report significantly better
general health and depression scores, and perform significantly better on tests of cognitive
performance in comparison to participants taking placebo.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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