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

Sponsor

Suellen Andrade (Other)

Overall Status

Completed

CT.gov ID

NCT05963958

Collaborator

City University of New York (Other)

Enrollment

Location

Arms

21.6

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Delirium Critical Illness	Combination Product: Active HD-tDCS Combination Product: Sham HD-tDCS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 14, 2021

Actual Primary Completion Date :

Dec 2, 2022

Actual Study Completion Date :

Jan 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Delirium Severity [28 days]
delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.

Secondary Outcome Measures

length of stay in the ICU and hospital stay [28 days]
defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge
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]
defined as the number of days free from mechanical ventilation for at least 48 consecutive hours
Exploratory analisys [28 days]
Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Paraiba	João Pessoa	Paraiba	Brazil	51051900

Sponsors and Collaborators

Suellen Andrade
City University of New York

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suellen Andrade, Principal Investigator, Federal University of Paraíba

ClinicalTrials.gov Identifier:

NCT05963958

Other Study ID Numbers:

Delirium/HD-tDCS

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Delirium

Critical Illness

Study Results

No Results Posted as of Jul 27, 2023