Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS

NCT04844554 — Not applicable, Unknown, 60 participants, Federal University of Paraíba

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Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS: Open Label, Randomized, Controlled Study

Registry	NCT04844554
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Federal University of Paraíba (Other); collaborators: City University of New York, University of Michigan, Rio de Janeiro State University
Conditions	Coronavirus, COVID-19 Respiratory Infection
Interventions	Active HD-tDCS 3mA, Sham HD-tDCS (Other)
Dates	start 2021-06-20, primary completion 2022-04-12 (estimated), completion 2022-10-12 (estimated), first posted 2021-04-14, last updated 2022-03-10
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1 - 3.0 mA active HD-tDCS	Experimental	Other: Active HD-tDCS 3mA	HD-tDCS with 3.0 milliamperes (mA) of intensitive
Group 2 - Sham HD-tDCS	Experimental	Other: Sham HD-tDCS	Sham HD-tDCS

Active HD-tDCS 3mA (Other): 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-tDCS (Other): 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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 20 Years to 90 Years

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).

+Locations (1)

Facility	City	Country	Status
Federal University of Paraíba,Department of Psychology	João Pessoa, Paraíba	Brazil	Recruiting