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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Subjects will undergo 5 sessions of tDCS of up to 2mA, at 20 minutes per session, 1x per day. During active stimulation, the current will be active for the full 20 minutes.
Subjects will undergo 5 sessions of tDCS, at 20 minutes per session, 1x per day. For sham tDCS, electrodes will be placed the same way as in the intervention group, for 20 minutes. However, the stimulator will deliver 2mA of current for only 30s. The current will not be active for the rest of the 20 minutes.
FUSaoPaulo
São Paulo, São Paulo, Brazil
Change in Fatigue
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.
Time frame: Change in fatigue from baseline to 15 days after the end of stimulation.
Change in Profile of Fatigue
Will be assessed with Profile of Fatigue and Discomfort - Sicca Symptoms Inventory (short form) (Profad-SSI-SF). Profad-SSI-SF is a 19-item questionnaire assessing the subjective aspects of the symptoms of Sjogren's Syndrome, including fatigue, based on the patient's perception. The items are scored from 0 to 7 points. Higher values indicate higher severity of fatigue.
Time frame: 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 assessed with EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI). ESSPRI is a very simple index designed to measure patients' symptoms of patients with Sjogren's Syndrome. ESSPRI is completed by the patient and it contains just three items to be given a score between 0-10: for pain, fatigue and dryness, the final ESSPRI score is the mean of all three scores and therefore also between 0-10. Higher values indicate higher severity of symptoms.
Time frame: 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 assessed with 12-Item Short-Form (SF-12). The SF-12 is a multipurpose short form survey with 12 questions. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: 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 Patient Global Assessment
Subjects will rate their global assessment using verbal response and a visual analog scale (0-10). They will rate: Global health.
Time frame: 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 Adverse Events
Subjects will complete a structured questionnaire to assess potential adverse events of stimulation
Time frame: Will be measured up to 30 days after the end of stimulation.
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