tDCS for Fatigue in Sjogren's Syndrome

NCT04119128 | Completed

• 1 other identifier: FederalUnivOfSaoPaulo
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Keywords

Sjogren's Syndrome; fatigue; tDCS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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 Adverse Events

  Will be measured up to 30 days after the end of stimulation.

Other Outcomes (4)

• 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.

• 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

• 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

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes.

Device: Active Transcranial Direct Current Stimulation

Sham tDCS

SHAM COMPARATOR

Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.

Device: Sham Transcranial Direct Current Stimulation

Interventions

Active Transcranial Direct Current Stimulation DEVICE

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.

Active tDCS

Sham Transcranial Direct Current Stimulation DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• University of Pittsburgh: collaborator
• Universidade Federal do Amapá: collaborator

Study Sites (1)

FUSaoPaulo

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Fatigue

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Pinto, MSc

  Federal University of Amapa/Federal University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: June 3, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after 6 months of study completion.
• Access Criteria: Data access request will be analysed and requestors will be required to sign a Data Access Agreement

Locations

BR (1)