CoronavirusNCT04844554
Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS
A study testing Active HD-tDCS 3mA in people with Coronavirus and COVID-19 Respiratory Infection, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
COVID-19 has a variety of symptoms from asymptomatic respiratory dysfunction to death. Considering the pathophysiology of SARS-CoV-2 and its relationship with the neuroimmune system, response, autonomic balance, musculoskeletal and respiratory and neuropsychiatric symptoms presented by patients, the investigators… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronavirus, COVID-19 Respiratory Infection
- What is being tested?
- Active HD-tDCS 3mA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2021to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Intensive Care Unit's Inclusion Criteria:
Patients of at least 18 years-old with a PCR-confirmed SARS-CoV-2 diagnosis and receiving mechanical ventilation at least 48 hours of meeting criteria for moderate to severe acute respiratory distress syndrome (ARDS), under weaning, were enrolled in this study. An ARDS diagnosis was made according to the Berlin Definition criteria.
Intensive Care Unit's Exclusion Criteria:
Patients were excluded if they had a condition that could prevent adequate performance of inspiratory muscle training (e.g., neuropathy or myopathy), pregnancy or active lactation, Richmond Agitation and Sedation Scale (RASS) scores between -2 and + 1, Glasgow Coma Scale (GCS) ≤ 8, consent refusal, and contraindications to brain stimulation (e.g., aneurysm clips).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900
Suellen Andrade, 986046032 ext. 55 83, suellenandrade@gmail.com
Suellen Andrade
About this study
Official title: Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS: Open Label, Randomized, Controlled Study
COVID-19 has a variety of symptoms from asymptomatic respiratory dysfunction to death. Considering the pathophysiology of SARS-CoV-2 and its relationship with the neuroimmune system, response, autonomic balance, musculoskeletal and respiratory and neuropsychiatric symptoms presented by patients, the investigators highlight the potential use of non-invasive neuromodulation methods to assess the effectiveness of treating patients with COVID-19, as these techniques can be useful in the management of important clinical aspects in the functional recovery of individuals affected by the disease.
The investigators intend to evaluate the effects of HD- tDCS to promote ventilatory weaning in patients admitted to the Intensive Care Unit (ICU) and to improve the respiratory performance of those hospitalized in nursing beds for treatment of COVID - 19.
- Conditions
- Coronavirus, COVID-19 Respiratory Infection
- Being tested
- Active HD-tDCS 3mA, Sham HD-tDCS
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active HD-tDCS 3mAOther
This group will receive HD-tDCS 3mA intensitie. 0 sessions at ICU simultaneously to physical rehabilitation. The HD- tDCS will be started with a 30 s ramp-up to the desired intensity, which was maintained for 20 min.
Sham HD-tDCSOther
This group will receive sham HD-tDCS. The intervention will be applied in 10 sessions at ICU simultaneously to physical rehabilitation. The HD- tDCS will be started with a 30 s ramp-up them turn off.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 3.0 mA active HD-tDCS | Experimental | HD-tDCS with 3.0 milliamperes (mA) of intensitive Receives: Other: Active HD-tDCS 3mA |
| Group 2 - Sham HD-tDCS | Experimental | Sham HD-tDCS Receives: Other: Sham HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU's primary outcome - number of days alive and free from mechanical ventilation
The primary outcome was ventilator-free days during the first 28 days, defined as the number of days alive and free from mechanical ventilation for at least 48 consecutive hours.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start20 Jun 2021
- Primary completion12 Apr 2022 (estimated)
- Study completion12 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- City University of New York, University of Michigan, Rio de Janeiro State University
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844554
- Sponsor's protocol ID
- COVID/hd-tDCS
- Status last verified
- Feb 2022
- First submitted
- 29 Mar 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS: Open Label, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04844554
- Acronym / sponsor ID
- COVID/hd-tDCS
- Conditions
- Coronavirus, COVID-19 Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- City University of New York, University of Michigan, Rio de Janeiro State University
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 12 Apr 2022 (estimated)
- Study completion
- 12 Oct 2022 (estimated)
- First posted
- 14 Apr 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.
COVID-19 has a variety of symptoms from asymptomatic respiratory dysfunction to death. Considering the pathophysiology of SARS-CoV-2 and its relationship with the neuroimmune system, response, autonomic balance, musculoskeletal and respiratory and neuropsychiatric symptoms presented by patients, the investigators highlight the potential use of non-invasive neuromodulation methods to assess the effectiveness of treating patients with COVID-19, as these techniques can be useful in the management of important clinical aspects in the functional recovery of individuals affected by the disease.
The investigators intend to evaluate the effects of HD- tDCS to promote ventilatory weaning in patients admitted to the Intensive Care Unit (ICU) and to improve the respiratory performance of those hospitalized in nursing beds for treatment of COVID - 19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 3.0 mA active HD-tDCS | Experimental | Other: Active HD-tDCS 3mAHD-tDCS with 3.0 milliamperes (mA) of intensitive |
| Group 2 - Sham HD-tDCS | Experimental | Other: Sham HD-tDCSSham HD-tDCS |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Active HD-tDCS 3mAThis group will receive HD-tDCS 3mA intensitie. 0 sessions at ICU simultaneously to physical rehabilitation. The HD- tDCS will be started with a 30 s ramp-up to the desired intensity, which was maintained for 20 min. | Other | Group 1 - 3.0 mA active HD-tDCS |
| Sham HD-tDCSThis group will receive sham HD-tDCS. The intervention will be applied in 10 sessions at ICU simultaneously to physical rehabilitation. The HD- tDCS will be started with a 30 s ramp-up them turn off. | Other | Group 2 - Sham HD-tDCS |
Primary outcome
ICU's primary outcome - number of days alive and free from mechanical ventilation
Time frame: 28 days
The primary outcome was ventilator-free days during the first 28 days, defined as the number of days alive and free from mechanical ventilation for at least 48 consecutive hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active HD-tDCS 3mA in people with Coronavirus and COVID-19 Respiratory Infection, run by Federal University of Paraíba 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?
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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade, Phd (986046032 ext. 5583, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU's primary outcome - number of days alive and free from mechanical ventilation (time frame: 28 days). 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 10 Mar 2022.