tDCS for Fatigue in Sjogren's Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active tDCS Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes. |
Device: Active Transcranial Direct Current Stimulation
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.
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| Sham Comparator: Sham tDCS Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes. |
Device: Sham Transcranial Direct Current Stimulation
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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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 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.
- 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
Other Outcome Measures
- Change in Hypothalamic-pituitary-adrenal (HPA) axis activity [Will be measured immediately before and immediately after the first day of stimulation and immediately before and immediately after the last day (5th) day of stimulation.]
Salivary cortisol
- Change in Sleep Quality [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 Pittsburgh Sleep Quality Index (PSQI). PSQI is a self-report questionnaire that assesses sleep quality. It's composed by nineteen individual items that generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The global PSQI score ranges from 0 to 21, where lower scores denote a healthier sleep quality.
- Change in Depression [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 using Beck Depression Inventory (BDI). BDI is a 21-item self-report inventory, for measuring the severity of depression. The items are scored from 0 to 3 points. Higher values indicate higher severity of depression.
- Change in Patient Self Assessment [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]
Subjects will rate their assessment using verbal response and a visual analog scale (0-10). They will rate: Anxiety, stress and sleepiness.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women
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Age between 18 and 65 years old;
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Diagnosis of primary Sjogren's Syndrome according to American-European Criteria;
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Stable pharmacological therapy for at least 3 months;
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Complaints of fatigue as assessed by Fatigue Severity Scale (FSS>5).
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Complaints of fatigue for more than 3 months.
Exclusion Criteria:
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Heart, coronary, respiratory, renal, or hepatic uncompensated insufficiencies;
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Uncompensated systemic arterial hypertension;
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Unable to answer the questionnaires.
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Severe depression (with a score > 30 in the Beck Depression Inventory)
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History of epilepsy or syncope
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Implanted brain metallic devices
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Established cognitive impairment
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Traumatic brain injury with residual neurological deficits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | FUSaoPaulo | Sao Paulo | SP | Brazil | 04024-002 |
Sponsors and Collaborators
- Federal University of São Paulo
- University of Pittsburgh
- Universidade Federal do Amapá
Investigators
- Principal Investigator: Ana Pinto, MSc, Federal University of Amapa/Federal University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FederalUnivOfSaoPaulo