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

Not Applicable

• Conditions: Coronavirus; COVID-19 Respiratory Infection
• Interventions: Other: Sham HD-tDCS; Other: Active HD-tDCS 3mA

• Registration Number: NCT04844554
• Lead Sponsor: Federal University of Paraíba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Study Start: 2021-06-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-10
• Primary Completion: 2022-04-12
• Study Completion: 2022-10-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Sham HD-tDCS	Sham HD-tDCS	Sham HD-tDCS
Group 1 - 3.0 mA active HD-tDCS	Active HD-tDCS 3mA	HD-tDCS with 3.0 milliamperes (mA) of intensitive

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Federal University of Paraíba,Department of Psychology; 🇧🇷 João Pessoa, Paraíba, Brazil