Berginstrom et al. (2017)

Sweden

RCT

PEDro=10

N=64

Population: TBI; Treatment Group (n=33): Mean Age=41.42yr; Gender: Male=17, Female=16; Mean Time Post Injury=8.58yr. Control Group (n=31): Mean Age=42.58yr; Gender: Male=20, Female=11; Mean Time Post Injury=8.10yr.

Intervention: (-)-OSU6162 was compared with placebo during a 4wk treatment period. 5mg of (-)-OSU6162 was given 2x/d in week 1, 10mg 2x/d in week 2, and 15mg 2x/d in weeks 3 and 4. Patients were evaluated at baseline, at days 7, 14, 22, and 28 during treatment, and for follow-up at 2 and 6mo.

Outcome Measure: Fatigue Severity Scale (FSS), Mental Fatigue Scale (MFS), Rivermead Post-Concussion Symptoms Questionnaire (RPCSQ).

1.        For the FSS, MFS, RPCSQ, and both groups showed significant improvement (all p<0.01) after the trial but not during follow-up. No between group differences were observed.

2.        During follow-up, the treatment group had significantly larger changes in folic acid (p=0.02), prolactin (p=0.03), and heart rate (p=0.009).