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

NCT05963958 | Completed

• 1 other identifier: Delirium/HD-tDCS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Delirium; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• length of stay in the ICU and hospital stay

  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

  28 days

• Exploratory analisys

  28 days

Study Arms (2)

Active HD-tDCS

EXPERIMENTAL

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

Sham HD-tDCS

PLACEBO COMPARATOR

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

Interventions

Active HD-tDCS COMBINATION_PRODUCT

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

Active HD-tDCS

Sham HD-tDCS COMBINATION_PRODUCT

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

Sham HD-tDCS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suellen Andrade: lead
• City University of New York: collaborator

Study Sites (1)

Federal University of Paraiba

João Pessoa, Paraíba, 51051900, Brazil

Location

MeSH Terms

Conditions

COVID-19; Delirium; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Applicators were blinded to who was receiving active stimulation and who was receiving placebo. The study drug was prepared by the nurses or nursing technicians, or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 27, 2023
• Study Start: April 14, 2021
• Primary Completion: December 2, 2022
• Study Completion: January 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)