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

F

Federal University of Paraíba

Status

Unknown

Conditions

COVID-19 Respiratory Infection
Coronavirus

Treatments

Other: Active HD-tDCS 3mA
Other: Sham HD-tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT04844554
COVID/hd-tDCS

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Maria Cecilia Silvestre; Suellen Andrade, Phd

Data sourced from clinicaltrials.gov

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