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

NCT ID: NCT05963958

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2023-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Active HD-tDCS

Intervention Type: 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

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).

Group Type: PLACEBO_COMPARATOR

Sham HD-tDCS

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City University of New York

OTHER

Sponsor Role: collaborator

Suellen Andrade

OTHER

Sponsor Role: lead

Responsible Party

Suellen Andrade

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Federal University of Paraiba

João Pessoa, Paraíba, Brazil

Countries

Brazil

Other Identifiers

Delirium/HD-tDCS

Identifier Type: -

Identifier Source: org_study_id