Transcranial direct current stimulation for fatigue in patients with Sjogren’s syndrome: A randomized, double-blind pilot study

BackgroundTranscranial direct-current stimulation (tDCS) has shown promise to decrease fatigue. However, it never been examined in primary Sjogren Syndrome (pSS).ObjectiveTo assess the effect of a tDCS protocol on fatigue patients with pSS.MethodsThis is parallel, double-blind pilot study (NCT04119128). Women aged 18–65 years, pSS, stable pharmacological therapy, complaints for at least three months, and scores >5 Fatigue Severity Scale (FSS) were included. We randomized 36 participants receive five consecutive or sham sessions, an intensity 2 mA, 20 min/day.ResultsAfter severity assessed by FSS (primary outcome) demonstrated mean group difference ?0.85 [95% confidence interval (CI) ?1.57, ?0.13; size 0.80] favouring active group. The presented significantly greater reductions as measured EULAR Sjögren’s Patient Reported Index after sessions [mean difference: 1.40; 95%CI -2.33, ?0.48; 1.04]. Although there no between-group differences secondary outcomes sleep, mood anxiety, within-group comparisons evidenced small but significant pain sleep. There cortisol changes. All reported adverse events mild transitory.ConclusiontDCS seems be safe reduce pSS. A differential sleep may underlie its effects. Further studies are needed optimise treatment strategies