tDCS in Post-Acute COVID-19 Patients With SARDs

Not Applicable

Recruiting

• Conditions: Autoimmune Diseases; Rheumatic Diseases
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT04890483
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2021-05-17
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Primary Completion: 2024-05-06
• Status Verified: 2024-12
• Study Completion: 2024-12-04
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Transcranial direct current stimulation	The ARD patients with post-acute COVID-19 will receive tDCS sessions for one week.

Primary Outcome Measures

Name	Time	Method
Frequency of treatment-emergent adverse events [safety and tolerability]	[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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Samuel K Shinjo; 🇧🇷 São Paulo, Brazil