tDCS in Post-Acute COVID-19 Patients With SARDs

NCT04890483 | Recruiting DMC

• 1 other identifier: MYO-HCFMUSP-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Diseases; Autoimmune Diseases

Outcome Measures

Primary Outcomes (4)

• 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.]

• 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.]

• 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.]

• 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 Outcomes (1)

• Health Assessment Questionnaire (HAQ)

  [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]

Study Arms (1)

Intervention

EXPERIMENTAL

The ARD patients with post-acute COVID-19 will receive tDCS sessions for one week.

Device: Transcranial direct current stimulation

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel K Shinjo

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases; Autoimmune Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Samuel K Shinjo, PhD

  Sao Paulo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel K Shinjo, PhD

CONTACT

551130617176; samuel.shinjo@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: May 17, 2021
• Primary Completion: May 6, 2024
• Study Completion: December 4, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

BR (1)