About Us

Research

Post-TBI Fatigue and Its Treatment

Principal Investigator: Wayne A. Gordon, Ph.D.
Co-Investigators: Joshua B. Cantor, Ph.D., Marcel Dijkers, Ph.D., Steven Flanagan, M.D.

Purpose: The purposes of this study are two: (1) to develop a better understanding of post-TBI fatigue and its correlates, and (2) to document the efficacy of the drug modafinil as a treatment for fatigue post TBI. The study will be done in two phases: Phase I will provide in-depth information about causes and consequences of fatigue; Phase II will evaluate modafinil’s impact on post-TBI fatigue.

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: Two needs are clear. First, little is known about fatigue in people with TBI; the results of research are simply inadequate to clarify how fatigue is triggered and its impact on people’s lives. Second, 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: In Phase I of this study, approximately 250 individuals with TBI – covering the full range of severity of fatigue, from low to high – will be recruited as study volunteers; 100 people with no disability who are similar to individuals in the TBI sample will also participate. Volunteers will be interviewed and evaluated to document the effects of a demanding activity on their performance on neuropsychological tests. Data will be analyzed to determine the relationship between fatigue and the individual’s participation in community life and sense of well being.

In Phase II, more than 100 men and women volunteers who complain of post-TBI fatigue will be randomly assigned to a 4-week period of taking medafinil or a placebo (i.e., sugar pill). Over the period of study, participants will be reminded regularly to take their medications. At the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., pain) will be assessed, as well as their participation in activities and perceived quality of life. It is hypothesized that medafinil will reduce the symptoms of fatigue and will increase the person’s level of activity and perceived quality of life to a significantly greater extent than will the placebo.