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

Coronavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844554
• Other study ID #: COVID/hd-tDCS
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: February 2022
• Source: Federal University of Paraíba
• Contact: Suellen Andrade, Phd
• Phone: 986046032
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Respiratory Tract Infections

Intervention

Other:
• Active 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.
• Sham 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.

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba,Department of Psychology	João Pessoa	Paraíba

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Paraíba	City University of New York, Rio de Janeiro State University, University of Michigan

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days