tDCS in Post-Acute COVID-19 Patients With SARDs
Primary Purpose
Rheumatic Diseases, Autoimmune Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatic Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients with well-defined ARDs (rheumatoid arthritis, sclerosis systemic, Sjögren syndrome, spondyloarthritis, systemic lupus erythematosus, systemic vasculitis, and systemic autoimmune myopathies)
- Fatigue or general pains.
Exclusion Criteria:
- Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies
Sites / Locations
- Samuel K ShinjoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
The ARD patients with post-acute COVID-19 will receive tDCS sessions for one week.
Outcomes
Primary Outcome Measures
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Secondary Outcome Measures
Health Assessment Questionnaire (HAQ)
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04890483
Brief Title
tDCS in Post-Acute COVID-19 Patients With SARDs
Official Title
Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
May 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Some patients develop "Post-acute COVID-19 syndrome," in which they experience persistent symptoms after recovering from the acute phase of COVID-19 infection. This syndrome may be more significant in patients with systemic autoimmune rheumatic diseases (SARDs) who have been suffering from several symptoms associated to SARDs, such as myalgia, fatigue, and general pains.
The transcranial direct current stimulation (tDCS) technique has been frequent, for example, to relieve fatigue and general pains in general population. However, to date, there are no studies evaluating this technique in ARD patients with post-acute COVID-19; therefore, the main objective of the opened study is to evaluate the safety and efficacy of the application of acute tDCS in ARD patients with post-acute COVID-19.
Detailed Description
Currently, there are no studies evaluating the tDCS technique in ARD patients with post-acute COVID-19; therefore, the main objective of the present study is to evaluate the safety and efficacy of the application of acute tDCS in these specific patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases, Autoimmune Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The ARD patients with post-acute COVID-19 will receive tDCS sessions for one week.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
tDCS: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes. During the session, patients will remain seated. Number of sessions: five times, once per day.
Primary Outcome Measure Information:
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time Frame
[Time Frame: After 30 minutes of transcranial stimulation.]
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time Frame
[Time Frame: After 5 sessions of transcranial stimulation.]
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time Frame
[Time Frame: After 30 days of transcranial stimulation.]
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time Frame
[Time Frame: After 60 days of transcranial stimulation.]
Secondary Outcome Measure Information:
Title
Health Assessment Questionnaire (HAQ)
Description
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Time Frame
[Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with well-defined ARDs (rheumatoid arthritis, sclerosis systemic, Sjögren syndrome, spondyloarthritis, systemic lupus erythematosus, systemic vasculitis, and systemic autoimmune myopathies)
Fatigue or general pains.
Exclusion Criteria:
Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel K Shinjo, PhD
Phone
551130617176
Ext
7176
Email
samuel.shinjo@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo, PhD
Organizational Affiliation
Sao Paulo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel K Shinjo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo, PhD
Phone
551130617176
Ext
7176
Email
samuel.shinjo@usp.br
12. IPD Sharing Statement
Learn more about this trial
tDCS in Post-Acute COVID-19 Patients With SARDs
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