Clinical trial NCT04119128: tDCS for Fatigue in Sjogren's Syndrome
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Syndrome
Keywords: Sjogren's Syndrome
fatigue
tDCS
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Universidade Federal do Amapá
First posted: 2019-10-08
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Fatigue
timeFrame: Change in fatigue from baseline to 15 days after the end of stimulation.
Secondary outcomes:
measure: Change in Profile of Fatigue
timeFrame: 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
measure: Change in Symptoms severity
timeFrame: 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
measure: Change in Quality of Life
timeFrame: 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
measure: Change in Patient Global Assessment
timeFrame: 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.
measure: Change in Adverse Events
timeFrame: Will be measured up to 30 days after the end of stimulation.
Other outcomes:
measure: Change in Hypothalamic-pituitary-adrenal (HPA) axis activity
timeFrame: 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.
measure: Change in Sleep Quality
timeFrame: 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
measure: Change in Depression
timeFrame: 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
measure: Change in Patient Self Assessment
timeFrame: 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
Locations:
city: Sao Paulo
country: Brazil
facility: FUSaoPaulo
state: SP
Study officials:
affiliation: Federal University of Amapa/Federal University of Sao Paulo
name: Ana Pinto, MSc
role: PRINCIPAL_INVESTIGATOR
References: