Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment

Study Overview
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Brief Summary
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Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Detailed Description
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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.

Official Title
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Post-TBI Fatigue and Its Treatment

Conditions
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Fatigue

Intervention / Treatment
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* Drug: Modafinil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Individuals who sustained a TBI with a documented loss of consciousness or evidence of a TBI on neuroimaging studies and who are at least 12 months post-injury, who complain of fatigue and who have scores of 22 or above on the Barroso Fatigue Scale will be eligible to participate in this study. Subjects must not meet criteria for alcohol or substance abuse using the Structured Clinical Interview for DSM-IV (SCID) for at least six months prior to study enrollment. Exclusion Criteria: - Diagnosis of chronic neurological disease (including Lyme disease), narcolepsy, current infectious disease, chronic fatigue syndrome, fibromyalgia, anemia, hypothyroidism not adequately controlled with medication, blood pressure greater 150/100 mm Hg, or clinically significant major systemic disease. In addition, individuals taking medications which are known to cause fatigue will be excluded from participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modafinil<br>single dose of 200 mg. a day of modafinil for four weeks | Drug: Modafinil<br>* single dose of 200 mg. a day of modafinil for four weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* daily dose of placebo for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Self-report of fatigue | comparison pre and post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Performance | Cognitive performance | comparison pre and post treatment | 
| Mood | mood | comparison pre and post treatment | 
| Pain | pain | comparison pre and post treatment | 
| Sleep Quality | sleep quality | comparison pre and post treatment | 
| Health Status | health status | comparison pre and post treatment | 
| Participation | participation | comparison pre and post treatment | 
| Quality of Life | quality of life | comparison pre and post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, TBI, brain injury, Modafinil, traumatic brain injury