Clinical trial NCT04890483: 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
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatic Diseases
Autoimmune Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: [Time Frame: After 30 minutes of transcranial stimulation.]
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: [Time Frame: After 5 sessions of transcranial stimulation.]
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: [Time Frame: After 30 days of transcranial stimulation.]
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: [Time Frame: After 60 days of transcranial stimulation.]
Secondary outcomes:
measure: Health Assessment Questionnaire (HAQ)
timeFrame: [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Samuel K Shinjo
Study officials:
affiliation: Sao Paulo University
name: Samuel K Shinjo, PhD
role: PRINCIPAL_INVESTIGATOR
References: