Back to resultstDCS for Fatigue in Sjogren's Syndrome
Primary Purpose
Sjogren's Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Sjogren's Syndrome focused on measuring Sjogren's Syndrome, fatigue, tDCS
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
Sites / Locations
- FUSaoPaulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes.
Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.
Outcomes
Primary Outcome Measures
Change in Fatigue
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
Change in Profile of Fatigue
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
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
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
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
Subjects will complete a structured questionnaire to assess potential adverse events of stimulation
Full Information
NCT ID
NCT04119128
First Posted
October 4, 2019
Last Updated
May 8, 2020
Sponsor
Federal University of São Paulo
Collaborators
University of Pittsburgh, Universidade Federal do Amapá
1. Study Identification
Unique Protocol Identification Number
NCT04119128
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
University of Pittsburgh, Universidade Federal do Amapá
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome
Keywords
Sjogren's Syndrome, fatigue, tDCS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation
Intervention Description
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
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
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 Measure Information:
Title
Change in Fatigue
Description
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.
Time Frame
Change in fatigue from baseline to 15 days after the end of stimulation.
Secondary Outcome Measure Information:
Title
Change in Profile of Fatigue
Description
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.
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
Title
Change in Symptoms severity
Description
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.
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
Title
Change in Quality of Life
Description
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.
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
Title
Change in Patient Global Assessment
Description
Subjects will rate their global assessment using verbal response and a visual analog scale (0-10). They will rate: Global health.
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.
Title
Change in Adverse Events
Description
Subjects will complete a structured questionnaire to assess potential adverse events of stimulation
Time Frame
Will be measured up to 30 days after the end of stimulation.
Other Pre-specified Outcome Measures:
Title
Change in Hypothalamic-pituitary-adrenal (HPA) axis activity
Description
Salivary cortisol
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.
Title
Change in Sleep Quality
Description
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.
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
Title
Change in Depression
Description
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.
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
Title
Change in Patient Self Assessment
Description
Subjects will rate their assessment using verbal response and a visual analog scale (0-10). They will rate: Anxiety, stress and 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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Pinto, MSc
Organizational Affiliation
Federal University of Amapa/Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
FUSaoPaulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04024-002
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all outcomes will be made available.
IPD Sharing Time Frame
Data will be available after 6 months of study completion.
IPD Sharing Access Criteria
Data access request will be analysed and requestors will be required to sign a Data Access Agreement
Learn more about this trial
tDCS for Fatigue in Sjogren's Syndrome
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