Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 14, 2021
CompletedStudy Start
First participant enrolled
June 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2022
CompletedMarch 10, 2022
February 1, 2022
10 months
March 29, 2021
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group 1 - 3.0 mA active HD-tDCS
EXPERIMENTALHD-tDCS with 3.0 milliamperes (mA) of intensitive
Group 2 - Sham HD-tDCS
EXPERIMENTALSham HD-tDCS
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federal University of Paraíbalead
- City University of New Yorkcollaborator
- University of Michigancollaborator
- Rio de Janeiro State Universitycollaborator
Study Sites (1)
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Researcher and Professor
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 14, 2021
Study Start
June 20, 2021
Primary Completion
April 12, 2022
Study Completion
October 12, 2022
Last Updated
March 10, 2022
Record last verified: 2022-02