Conditions: Fatigue
Keywords: Fatigue TBI brain injury Modafinil traumatic brain injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief summary:
Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Detailed description:
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.

Arms:
arm 1: single dose of 200 mg. a day of modafinil for four weeks arm 2: None

Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: single dose of 200 mg. a day of modafinil for four weeks intervention 2: daily dose of placebo for four weeks.

Protocol document: