Abstract:
It is estimated that there are 5.3 million Americans living with a traumatic brain injury (TBI) related disability today. Fatigue and excessive daytime sleepiness appear to be common problems reported by individuals who have sustained TBI. These symptoms have a detrimental effect on all aspects of a person.s daily life. Modafinil is an FDA-approved wakefulness promoting agent for individuals with excessive daytime sleepiness associated with narcolepsy. It has also been found to be effective in reducing fatigue and sleepiness in persons with multiple sclerosis, fibromyalgia, Parkinson.s disease and depression. Some evidence suggests that if Modafinil is effective in reducing fatigue and sleepiness that this may lead to improved cognitive function and quality of life, which are also problems associated with TBI. Nevertheless, the use of this drug in individuals with TBI has not been systematically explored. This study is using a randomized double-blind placebo-controlled crossover study design to investigate the efficacy of Modafinil for the management of fatigue and excessive daytime sleepiness in individuals with TBI. If Modafinil is found to be effective, it may also have the potential to improve cognitive function and the quality of life in these individuals. Project Status: Data collection will be completed by 02/2005.