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

Sponsor
Federal University of Paraíba (Other)
Overall Status
Recruiting
CT.gov ID
NCT04844554
Collaborator
City University of New York (Other), University of Michigan (Other), Rio de Janeiro State University (Other)
60
1
2
15.7
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Active HD-tDCS 3mA
  • Other: Sham HD-tDCS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS: Open Label, Randomized, Controlled Study
Actual Study Start Date :
Jun 20, 2021
Anticipated Primary Completion Date :
Apr 12, 2022
Anticipated Study Completion Date :
Oct 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 - 3.0 mA active HD-tDCS

HD-tDCS with 3.0 milliamperes (mA) of intensitive

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.

Experimental: Group 2 - Sham HD-tDCS

Sham HD-tDCS

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Paraíba,Department of Psychology João Pessoa Paraíba Brazil 58051-900

Sponsors and Collaborators

  • Federal University of Paraíba
  • City University of New York
  • University of Michigan
  • Rio de Janeiro State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suellen Marinho Andrade, Principal Researcher and Professor, Federal University of Paraíba
ClinicalTrials.gov Identifier:
NCT04844554
Other Study ID Numbers:
  • COVID/hd-tDCS
First Posted:
Apr 14, 2021
Last Update Posted:
Mar 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022