tDCS for Fatigue in Sjogren's Syndrome

Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial

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 Overview

• Status: Completed
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Device: Active Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04024-002
      • FUSãoPaulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in fatigue from baseline to 15 days after the end of stimulation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	Will be measured up to 30 days after the end of stimulation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hypothalamic-pituitary-adrenal (HPA) axis activity	Salivary cortisol	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.
Change in Sleep Quality	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.	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 Depression	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.	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 Self Assessment	Subjects will rate their assessment using verbal response and a visual analog scale (0-10). They will rate: Anxiety, stress and sleepiness.	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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: University of Pittsburgh; Universidade Federal do Amapá
• Investigators: Principal Investigator: Ana Pinto, MSc, Federal University of Amapa/Federal University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 5, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: tDCS; fatigue; Sjogren's Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Fatigue; Sjogren's Syndrome
• Other Study ID Numbers: FederalUnivOfSaoPaulo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all outcomes will be made available.
• IPD Sharing Time Frame: Data will be available after 6 months of study completion.
• IPD Sharing Access Criteria: Data access request will be analysed and requestors will be required to sign a Data Access Agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No