Menu
Recruiting NCT04890483

tDCS in Post-Acute COVID-19 Patients With SARDs

No phase Interventional Rheumatic Diseases Autoimmune Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial direct current stimulation.
Who it may be relevant to
Registry conditions: Rheumatic Diseases, Autoimmune Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases

Overview

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

  • Device Transcranial 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 dir

Primary outcome measures

  • Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: [Time Frame: After 30 minutes of transcranial stimulation.]]
  • Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: [Time Frame: After 5 sessions of transcranial stimulation.]]
  • Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: [Time Frame: After 30 days of transcranial stimulation.]]
  • Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: [Time Frame: After 60 days of transcranial stimulation.]]
Secondary outcome measures (1)
  • Health Assessment Questionnaire (HAQ) [Time frame: [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Samuel K Shinjo — São Paulo

Identifiers

NCT: NCT04890483 · MYO-HCFMUSP-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗