Autoimmune Diseases, Rheumatic Diseases
Conditions
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.
Interventions
DEVICETranscranial direct current stimulation
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.
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of treatment-emergent adverse events [safety and tolerability] | [Time Frame: After 30 minutes of transcranial stimulation.] | Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Assessment Questionnaire (HAQ) | [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation] | Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst) |
Countries
Brazil
Contacts
Primary ContactSamuel K Shinjo, PhD
Outcome results
None listed