tDCS for Fatigue in Sjogren's Syndrome
- Conditions
- Sjogren's Syndrome
- Interventions
- Device: Active Transcranial Direct Current StimulationDevice: Sham Transcranial Direct Current Stimulation
- Registration Number
- NCT04119128
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
- Women
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active tDCS Active Transcranial Direct Current Stimulation Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes. Sham tDCS Sham Transcranial Direct Current Stimulation Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.
- Primary Outcome Measures
Name Time Method Change in Fatigue 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
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 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.
Change in Adverse Events Will be measured up to 30 days after the end of stimulation. Subjects will complete a structured questionnaire to assess potential adverse events of stimulation
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. Subjects will rate their global assessment using verbal response and a visual analog scale (0-10). They will rate: Global health.
Trial Locations
- Locations (1)
FUSaoPaulo
🇧🇷Sao Paulo, SP, Brazil