Rheumatic DiseasesNCT04890483
tDCS in Post-Acute COVID-19 Patients With SARDs
A study testing Transcranial direct current stimulation in people with Rheumatic Diseases and Autoimmune Diseases, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatic Diseases, Autoimmune Diseases
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 17 May 2021to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Samuel K Shinjo
São Paulo
Samuel K Shinjo, PhD, 551130617176 ext. 7176, samuel.shinjo@usp.br
About this study
Official title: Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases
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.
Read the 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.
- Conditions
- Rheumatic Diseases, Autoimmune Diseases
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Rheumatic Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The ARD patients with post-acute COVID-19 will receive tDCS sessions for one week. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: [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)
Measured: [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)
Measured: [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)
Measured: [Time Frame: After 60 days of transcranial stimulation.]
Secondary outcomes (1)
Health Assessment Questionnaire (HAQ)
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Measured: [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start17 May 2021
- Primary completion6 May 2024
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
- Investigators
- Samuel K Shinjo, PhD, Principal investigator, Sao Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890483
- Sponsor's protocol ID
- MYO-HCFMUSP-09
- Status last verified
- Dec 2024
- First submitted
- 17 May 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in Post-Acute COVID-19 Patients With Systemic Autoimmune Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04890483
- Acronym / sponsor ID
- MYO-HCFMUSP-09
- Conditions
- Rheumatic Diseases, Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label uncontrolled study of application of tDCS sessions in ARD patients with post-acute COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Transcranial direct current stimulationThe ARD patients with post-acute COVID-19 will receive tDCS sessions for one week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationtDCS: 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. | Device | Intervention |
Primary outcome
Frequency of treatment-emergent adverse events [safety and tolerability]
Time frame: [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)
Frequency of treatment-emergent adverse events [safety and tolerability]
Time frame: [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)
Frequency of treatment-emergent adverse events [safety and tolerability]
Time frame: [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)
Frequency of treatment-emergent adverse events [safety and tolerability]
Time frame: [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)
1 secondary outcome
Health Assessment Questionnaire (HAQ)
Time frame: [Time Frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) one and (c) two months after stimulation]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel K Shinjo, PhD principal investigator
Sao Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Rheumatic Diseases and Autoimmune Diseases, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel K Shinjo, PhD (551130617176 ext. 7176, samuel.shinjo@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent adverse events [safety and tolerability] (time frame: [Time Frame: After 30 minutes of transcranial stimulation.]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.