tDCS in Post-Acute COVID-19 Patients With SARDs

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890483
• Other study ID #: MYO-HCFMUSP-09
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Samuel K Shinjo, PhD
• Phone: 551130617176
• Email: samuel.shinjo[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 7, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Collagen Diseases
• Rheumatic Diseases

Intervention

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 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.

Locations

Country	Name	City	State
Brazil	Samuel K Shinjo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	[Time Frame: After 30 minutes of transcranial stimulation.]
Primary	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)	[Time Frame: After 5 sessions of transcranial stimulation.]
Primary	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)	[Time Frame: After 30 days of transcranial stimulation.]
Primary	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)	[Time Frame: After 60 days of transcranial stimulation.]
Secondary	Health Assessment Questionnaire (HAQ)	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)	[Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]