Kaiser et al. (2010)
Switzerland
RCT
PEDro=9
N=20 |
Population: TBI=20; Gender: Male=17, Female=3. Treatment Group (n=10): Mean Age=37yr; Severity: Mean GCS=7. Control Group (n=10): Mean Age=43yr; Severity: Mean GCS=8.
Intervention: Patients received either 100-200mg modafinil or placebo every morning for 6wk.
Outcome Measure: Excessive Daytime Sleepiness (EDS), Fatigue Severity Scale (FSS), Maintenance of Wakefulness Test (MWT). |
1. The modafinil group had greater decreases in EDS scores versus placebo (p<0.005).
2. On the MWT, a significantly greater improvement was shown for the modafinil group when compared to placebo (8.4± 9.6 versus 0.4± 6.2 min, p=0.04). |
Jha et al. (2008)
USA
RCT
PEDro=8
NInitial=51, NFinal=46 |
Population: TBI=51; Mean Age=38.25yr; Gender: Male=35, Female=16; Mean Time Post Injury=5.77yr.
Intervention: The treatment group (n=27) received modafinil (100 mg/d for 3d, then 200 mg/d for 11d, then a maintenance dose of 400 mg/d for 8wk). The control group (n=24) received a placebo. At the end of phase 1 (8wk) both groups crossed-over.Outcome Measure: Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFI), Epworth Sleepiness Scale (ESS). |
1. The change in ESS scores was significantly greater in the modafinil group versus placebo at 4wk (p=0.02) but not at 10wk (p=0.56).
2. Adverse events for the treatment group included: headaches (29.5%), insomnia (19.6%), fatigue (9.8%), dizziness (7.8%), and tremors (5.9%).
Adverse events for placebo: headaches (19.6%) and nasoppharyngitis (5.9%). |