tDCS in Post-Acute COVID-19 Patients With SARDs

NCT ID: NCT04890483

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2024-12-04

Brief Summary

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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

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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.

Conditions

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Rheumatic Diseases Autoimmune Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Samuel Katsuyuki Shinjo, PhD

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel K Shinjo, PhD

Role: PRINCIPAL_INVESTIGATOR

Sao Paulo University

Locations

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Samuel K Shinjo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Samuel K Shinjo, PhD

Role: CONTACT

Phone: 551130617176

Email: [email protected]

Facility Contacts

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Samuel K Shinjo, PhD

Role: primary

Other Identifiers

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MYO-HCFMUSP-09

Identifier Type: -

Identifier Source: org_study_id