Coronavirus, COVID-19 Respiratory Infection
Conditions
Brief 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 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.
Interventions
OTHERActive HD-tDCS 3mA
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.
OTHERSham HD-tDCS
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.
Sponsors
City University of New York
University of Michigan
Rio de Janeiro State University
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU's primary outcome - number of days alive and free from mechanical ventilation | 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. |
Countries
Brazil
Contacts
Primary ContactSuellen Andrade, Phd
Backup ContactMaria Cecilia Silvestre
Outcome results
None listed