Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04890483

tDCS in Post-Acute COVID-19 Patients With SARDs

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Rheumatic Diseases Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samuel K Shinjo

São Paulo, Brazil

Location status: Recruiting

Location contact

Samuel K Shinjo, PhD

CONTACT

[email protected]

551130617176 ext. 7176

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 outcomes

  1. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: [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)

  2. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: [Time Frame: After 5 sessions of transcranial stimulation.]

    Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)

  3. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: [Time Frame: After 30 days of transcranial stimulation.]

    Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)

  4. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: [Time Frame: After 60 days of transcranial stimulation.]

    Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)

Secondary outcomes

  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]

    Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel K Shinjo, PhD

CONTACT

[email protected]

551130617176 ext. 7176

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.