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

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

Early mobilization for children in intensive therapy: A protocol for systematic review and meta-analysis.

INTRODUCTION: Intensive care units focus primarily on life support and treatment of critically ill patients, but there are many survivors with complications, such as generalized muscle disorders, functional disability and reduced quality of life after hospital discharge, resulting from prolonged stays in these units. The current evidence suggests that early mobilization-based rehabilitation (exercise initiated immediately after the patient's significant physiological changes have stabilized) in critically ill adults can alleviate these complications from immobility and critical illness. However, there are a lack of practice guidelines, conflicting perceptions about safety, and knowledge gaps about benefits in the critically ill paediatric population. Therefore, we aim to assess the effects of early mobilization for children in intensive therapy. METHODS AND ANALYSIS: Systematic searches will be carried out in Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cochrane Central Register of Controlled Trials, Latin American and Caribbean Centre on Health Sciences Information, Cumulative Index to Nursing & Allied Health Literature and physiotherapy evidence database databases at a minimum without date or language restrictions for relevant individual parallel, cross-over and cluster randomized controlled trials. In addition, a search will also be carried out in the World Health Organization International Clinical Trials Registry Platform, and in the clinical trial registries of ClinicalTrials.gov, looking for any on-going randomised controlled trials that compare early mobilization with any other type of intervention. Two review authors will independently perform data extraction and quality assessments of data from included studies, and any disagreements will be resolved by discussion or by arbitration. The primary outcomes will be mortality and adverse events. Secondary outcomes will include duration of critical care (days), duration of mechanical ventilation support, muscle strength, pain and neuropsychomotor development. The Cochrane handbook will be used for guidance. If the results are not appropriate for a meta-analysis in RevMan 5 software (e.g., if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. ETHICS AND DISSEMINATION: This protocol was prospectively registered at Open Science Framework and approved by the Ethics and Research Committee of the Federal University of Sao Paulo (8543210519). We intend to update the public registry used in this review, report any important protocol amendments and publish the results in a widely accessible journal. REGISTRATION:: osf.io/ebju9.