tDCS for Fatigue in Sjogren's Syndrome

NCT ID: NCT04119128

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2020-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active tDCS

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

Group Type: ACTIVE_COMPARATOR

Active Transcranial Direct Current Stimulation

Intervention Type: 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.

Sham tDCS

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

Group Type: SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Universidade Federal do Amapá

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ana Carolina Pereira Nunes Pinto

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Pinto, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Amapa/Federal University of Sao Paulo

Locations

FUSaoPaulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

FederalUnivOfSaoPaulo

Identifier Type: -

Identifier Source: org_study_id