tDCS for Fatigue in Sjogren's Syndrome

Federal University of São Paulo

Status: Completed

Conditions: Sjogren's Syndrome

Treatments: Device: Sham Transcranial Direct Current Stimulation; Device: Active Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04119128

FederalUnivOfSaoPaulo

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Active tDCS

Active Comparator group

Description:

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

Treatment:

Device: Active Transcranial Direct Current Stimulation

Sham tDCS

Sham Comparator group

Description:

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

Treatment:

Device: Sham Transcranial Direct Current Stimulation