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

Suellen Andrade

Status: Completed

Conditions: COVID-19; Delirium; Critical Illness

Treatments: Combination Product: Sham HD-tDCS; Combination Product: Active HD-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05963958

Delirium/HD-tDCS

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Active HD-tDCS

Experimental group

Description:

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).

Treatment:

Combination Product: Active HD-tDCS

Sham HD-tDCS

Placebo Comparator group

Description:

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).

Treatment:

Combination Product: Sham HD-tDCS