Clincosm LogoSign in Get a demo

tDCS in Post-Acute COVID-19 Patients With SARDs

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04890483
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
19.3
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct current stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases
Actual Study Start Date :
May 17, 2021
Actual Primary Completion Date :
May 17, 2021
Anticipated Study Completion Date :
Dec 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

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.

Outcome Measures

Primary Outcome Measures

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

  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]]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samuel K Shinjo São Paulo Brazil

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • Principal Investigator: Samuel K Shinjo, PhD, Sao Paulo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samuel Katsuyuki Shinjo, PhD, Professor, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT04890483
Other Study ID Numbers:
  • MYO-HCFMUSP-09
First Posted:
May 18, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rheumatic Diseases
Collagen Diseases
Autoimmune Diseases

Study Results

No Results Posted as of Jun 1, 2022