Effects of Transcranial Direct Current Stimulation (tDCS) on Fatigue in Patients With Primary Sjogren's Syndrome: a Double-blinded Randomized Trial
tDCS for Fatigue in Sjogren's Syndrome
Sponsors
Lead Sponsor
Collaborators
Source
Federal University of São Paulo
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Recruiting
Start Date
2019-06-03
Completion Date
2020-10-01
Primary Completion Date
2020-06-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in Fatigue |
Change in fatigue from baseline to 15 days after the end of stimulation. |
Secondary Outcome
Measure |
Time Frame |
|
Change in Profile of Fatigue |
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 |
|
Change in Hypothalamic-pituitary-adrenal (HPA) axis activity |
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. |
|
Change in Adverse Events |
Will be measured up to 30 days after the end of stimulation. |
|
Change in Sleep Quality |
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 |
|
Change in Sleepiness |
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 |
|
Change in Symptoms severity |
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 |
|
Change in Depression |
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 |
|
Change in Quality of Life |
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 |
|
Change in Pain |
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 |
|
Change in Patient Global Assessment |
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. |
|
Change in Physical activity status |
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 |
Enrollment
36
Condition
Intervention
Intervention Type
Device
Intervention Name
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.
Arm Group Label
Active tDCS
Intervention Type
Device
Intervention Name
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.
Arm Group Label
Sham 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 since at least one month;
- 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;
- Patients with another inflammatory diseases;
- Unable to perform the proposed exercises.
- 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
Gender
Female
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ana Pinto, MSc |
Principal Investigator |
Federal University of Amapa/Federal University of Sao Paulo |
Overall Contact
Location
Facility |
Status |
Contact |
|
FUSaoPaulo Sao Paulo SP 04024-002 Brazil |
Recruiting |
Location Countries
Country
Brazil
Verification Date
2019-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Federal University of São Paulo
Investigator Full Name
Ana Carolina Pereira Nunes Pinto
Investigator Title
MSc
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Active tDCS
Arm Group Type
Active Comparator
Description
Patients in this group will receive 5 active sessions of low-intensity transcranial electrical stimulation for 20 minutes.
Arm Group Label
Sham tDCS
Arm Group Type
Sham Comparator
Description
Patients in this group will receive 5 sessions of sham transcranial electrical stimulation for 20 minutes.
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
Yes
Ipd Description
De-identified individual participant data for all outcomes will be made available.
Ipd Info Type
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Ipd Time Frame
Data will be available after 6 months of study completion.
Ipd Access Criteria
Data access request will be analysed and requestors will be required to sign a Data Access Agreement
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
October 4, 2019
Study First Submitted Qc
October 5, 2019
Study First Posted
October 8, 2019
Last Update Submitted
October 5, 2019
Last Update Submitted Qc
October 5, 2019
Last Update Posted
October 8, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.