Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Fatigue
研究概览
简要总结
Sjogren's Syndrome (SS) is an autoimune disease of unknown etiology characterized by lymphocytic infiltration of the exocrine glands and other organs. patients usually presents with xerophthalmia, xerostomia, fatigue and other symptoms. Fatigue has often been reported as the biggest problem and the most difficult symptom patients have to deal with. Fatigue management in pSS is difficult. However, in other diseases such as Parkinson disease, post-polio syndrome and multiple sclerosis the use of Transcranial Direct Current Stimulation (tDCS) has recently been studied and has shown effectiveness. The overarching objective of this study is to examine the effect of a tDCS protocol in patients with pSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old;
- •Diagnosis of primary Sjogren's Syndrome according to American-European Criteria;
- •Stable pharmacological therapy for at least 3 months;
- •Complaints of fatigue as assessed by Fatigue Severity Scale (FSS>5).
- •Complaints of fatigue for more than 3 months.
排除标准
- •Heart, coronary, respiratory, renal, or hepatic uncompensated insufficiencies;
- •Uncompensated systemic arterial hypertension;
- •Unable to answer the questionnaires.
- •Severe depression (with a score > 30 in the Beck Depression Inventory)
- •History of epilepsy or syncope
- •Implanted brain metallic devices
- •Established cognitive impairment
- •Traumatic brain injury with residual neurological deficits
结局指标
主要结局
Change in Fatigue
时间窗: Change in fatigue from baseline to 15 days after the end of stimulation.
Will be assessed with Fatigue Severity Scale (FSS). FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7-point scale. Higher values indicate higher severity of fatigue.
次要结局
- Change in Patient Global Assessment(Will be measured after the 1st, 5th day of stimulation, 15 days after the end of stimulation and 30 days after the end of stimulation.)
- Change in Profile of Fatigue(Will be measured at baseline, on the 5th day of stimulation (immediately after the end of stimulation), 15 days after the end of stimulation and 30 days after the end of stimulation)
- Change in Symptoms severity(Will be measured at baseline, on the 5th day of stimulation (immediately after the end of stimulation), 15 days after the end of stimulation and 30 days after the end of stimulation)
- Change in Quality of Life(Will be measured at baseline, on the 5th day of stimulation (immediately after the end of stimulation), 15 days after the end of stimulation and 30 days after the end of stimulation)
- Change in Adverse Events(Will be measured up to 30 days after the end of stimulation.)
研究者
Ana Carolina Pereira Nunes Pinto
MSc
Federal University of São Paulo