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tDCS for Fatigue in Sjogren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119128
Recruitment Status : Active, not recruiting
First Posted : October 8, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
University of Pittsburgh
Universidade Federal do Amapá
Information provided by (Responsible Party):
Ana Carolina Pereira Nunes Pinto, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Device: Active Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Fatigue [ Time Frame: Change in fatigue from baseline to 15 days after the end of stimulation. ]
    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.


Secondary Outcome Measures :
  1. Change in Profile of Fatigue [ Time Frame: 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 ]
    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.

  2. Change in Symptoms severity [ Time Frame: 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 ]
    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.

  3. Change in Quality of Life [ Time Frame: 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 ]
    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.

  4. Change in Patient Global Assessment [ Time Frame: 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. ]
    Subjects will rate their global assessment using verbal response and a visual analog scale (0-10). They will rate: Global health.

  5. Change in Adverse Events [ Time Frame: Will be measured up to 30 days after the end of stimulation. ]
    Subjects will complete a structured questionnaire to assess potential adverse events of stimulation


Other Outcome Measures:
  1. Change in Hypothalamic-pituitary-adrenal (HPA) axis activity [ Time Frame: 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. ]
    Salivary cortisol

  2. Change in Sleep Quality [ Time Frame: 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 ]
    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.

  3. Change in Depression [ Time Frame: 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 ]
    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.

  4. Change in Patient Self Assessment [ Time Frame: 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 ]
    Subjects will rate their assessment using verbal response and a visual analog scale (0-10). They will rate: Anxiety, stress and sleepiness.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119128


Locations
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Brazil
FUSaoPaulo
Sao Paulo, SP, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
University of Pittsburgh
Universidade Federal do Amapá
Investigators
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Principal Investigator: Ana Pinto, MSc Federal University of Amapa/Federal University of Sao Paulo

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Responsible Party: Ana Carolina Pereira Nunes Pinto, MSc, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT04119128    
Other Study ID Numbers: FederalUnivOfSaoPaulo
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcomes will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Carolina Pereira Nunes Pinto, Federal University of São Paulo:
Sjogren's Syndrome
fatigue
tDCS
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
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
Autoimmune Diseases
Immune System Diseases