HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19 (COVID-19)

HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19

The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.

Study Overview

• Status: Completed
• Conditions: COVID-19; Delirium; Critical Illness
• Intervention / Treatment: Combination product: Active HD-tDCS; Combination product: Sham HD-tDCS

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraiba
    • João Pessoa, Paraiba, Brazil, 51051900
      • Federal University of Paraíba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥18 years,
• confirmed clinical diagnosis for SARS-CoV-2,
• delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators

Exclusion Criteria:

• severe psychiatric illness that is not well controlled;
• pregnancy or active lactation,
• refusal of consent
• contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active HD-tDCS; HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).	Combination product: Active HD-tDCS; Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
Placebo Comparator: Sham HD-tDCS; HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).	Combination product: Sham HD-tDCS; Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium Severity	delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay in the ICU and hospital stay	defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge	28 days
Occurrence of hypotension requiring any vasopressor administration		28 days
C-reactive protein levels		28 days
ventilator-free days during the first 28 days	defined as the number of days free from mechanical ventilation for at least 48 consecutive hours	28 days
Exploratory analisys	Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis	28 days

Collaborators and Investigators

• Sponsor: Suellen Andrade
• Collaborators: City University of New York

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; COVID-19; Delirium; Critical Illness
• Other Study ID Numbers: Delirium/HD-tDCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No