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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

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04119128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2019)
  • 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.
  • 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
  • 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
  • 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.
  • Change in Sleepiness [ 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 Epworth Sleepiness Scale. The Epworth Sleepiness Scale is a 8-item scale that measures sleepiness. The items are scored from 0 to 3 points. Higher values indicate higher severity of sleepiness.
  • 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.
  • 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.
  • 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.
  • Change in Pain [ 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 McGill pain tool
  • Change in Patient Global Assessment [ Time Frame: Will be measured after the 1st, 2nd, 3rd, 4th and 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, anxiety, stress, depression, pain, fatigue, sleep quality and sleepiness.
  • Change in Physical activity status [ 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 the short version of the International Physical Activity Questionnaire (IPAQ). IPAQ consists of a series of questions to estimate the frequency, intensity and duration of physical activity of the individual in a normal week.
Current Other Pre-specified Outcome Measures
 (submitted: January 8, 2020)
  • 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
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE tDCS for Fatigue in Sjogren's Syndrome
Official Title  ICMJE Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sjogren's Syndrome
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Active tDCS
    Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes.
    Intervention: Device: Active Transcranial Direct Current Stimulation
  • Sham Comparator: Sham tDCS
    Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.
    Intervention: Device: Sham Transcranial Direct Current Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04119128
Other Study ID Numbers  ICMJE FederalUnivOfSaoPaulo
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcomes will be made available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Ana Carolina Pereira Nunes Pinto, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE
  • University of Pittsburgh
  • Universidade Federal do Amapá
Investigators  ICMJE
Principal Investigator: Ana Pinto, MSc Federal University of Amapa/Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP