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

Primary Purpose

Coronavirus, COVID-19 Respiratory Infection

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active HD-tDCS 3mA
Sham HD-tDCS
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Federal University of Paraíba,Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 - 3.0 mA active HD-tDCS

Group 2 - Sham HD-tDCS

Arm Description

HD-tDCS with 3.0 milliamperes (mA) of intensitive

Sham HD-tDCS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
February 23, 2022
Sponsor
Federal University of Paraíba
Collaborators
City University of New York, University of Michigan, Rio de Janeiro State University
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1. Study Identification

Unique Protocol Identification Number
NCT04844554
Brief Title
Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS
Official Title
Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS: Open Label, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
April 12, 2022 (Anticipated)
Study Completion Date
October 12, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
Collaborators
City University of New York, University of Michigan, Rio de Janeiro State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, COVID-19 Respiratory Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - 3.0 mA active HD-tDCS
Arm Type
Experimental
Arm Description
HD-tDCS with 3.0 milliamperes (mA) of intensitive
Arm Title
Group 2 - Sham HD-tDCS
Arm Type
Experimental
Arm Description
Sham HD-tDCS
Intervention Type
Other
Intervention Name(s)
Active HD-tDCS 3mA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham HD-tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
ICU's primary outcome - number of days alive and free from mechanical ventilation
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Andrade, Phd
Phone
986046032
Ext
5583
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Cecilia Silvestre
Phone
996381737
Ext
5584
Email
ceciliasilvestre.to@gmail.com
Facility Information:
Facility Name
Federal University of Paraíba,Department of Psychology
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Phone
986046032
Ext
55 83
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Suellen Andrade

12. IPD Sharing Statement

Learn more about this trial

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

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