Kaiser et al. (2010)

Switzerland

RCT

PEDro=9

N=20

Population: TBI=20; Gender: Male=17, Female=3. Treatment Group: N=10; Mean Age=37 yr; Mean GCS Score=7; Control Group: N=10; Mean Age=43 yr; Mean GCS Score=8.

Intervention: Actigraphy and nocturnal polysomnography at baseline. Patients received either modafinil (100 mg 1×/day then 2×/day) or placebo for 6 wk.

Outcome Measure: Excessive Daytime Sleepiness (EDS), Fatigue Severity Scale (FSS), and Maintenance of wakefulness test (MWT).

1.        At 6 wk, the decrease in FSS scores was greater in the modafinil group (-0.8±1.0 versus 0.0±0.6), but this was not significant (p=0.07).

2.        The modafinil group had greater decreases in EDS scores versus placebo (p<0.005).

3.        On the MWT, a significant increase was shown for the modafinil group when compared to placebo (8.4±9.6 min versus 0.4±6.2 min; p=0.04).

4.        Of those patients with fatigue at baseline (FSS≥4), decreases in FSS scores were not greater in the intervention group.

Jha et al. (2008)

USA

RCT

PEDro=8

N_initial=51, N_final=46

Population: TBI=51; Mean Age=38.25 yr; Gender: Male=35, Female=16; Mean Time Post Injury=5.77 yr.

Intervention: Intervention group (n=27) received modafinil (100 mg 1×/day for 3 days, then 2×/day for 11 days). A maintenance dose of 100 mg was given 2×/day. The control group (n=24) received a placebo. At the end of phase 1 both groups crossed-over.

Outcome Measure: Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFI), and Epworth Sleepiness Scale (ESS).

1.        No significant between group differences were found at week 4 or week 10 on the FSS (p=0.80 and p=0.61, respectively) or the MFI (p=0.67 and p=0.73, respectively).

2.        The change in ESS scores was significantly greater in the modafinil group versus placebo at week 4 (p=0.02) but not at week 10 (p=0.56).

3.        Adverse events included: headaches (29.5%), insomnia (19.6%), fatigue (9.8%), dizziness (7.8%) and tremors (5.9%).