Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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Pain management for sedated ICU patients is complex, partly because of the difficulty of assessing pain in non-communicative patients, and partly because of the side effects associated with excessive use of morphine.

In this context, the use of another non-pharmacological approach, transcranial direct current stimulation (tDCS), could be of interest. With tDCS, neuronal activity is modulated by inducing a weak electric current through the cerebral cortex between two electrodes applied to the surface of the scalp. Although the mechanisms of action of tDCS are not yet fully understood, the medium-term effects are thought to be linked to the activation of N-methyl-D-aspartate receptors, glutamate-activated receptors involved in cellular memory. The use of tDCS as an analgesic therapy for chronic pain has produced encouraging results in patients suffering from fibromyalgia, migraine and central pain following spinal cord injury, Its use in sedated intensive care patients is unknown. To assess the possible analgesic effect of tDCS in these patients, we will use quantitative pupillometry, a technique already used in routine intensive care, to quantify nociception during a standardized nociceptive simulation.

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Detailed Description

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Conditions

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Transcranial Direct Current Stimulation (tDCS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* Active tDCS stimulation ;
* Placebo tDCS stimulation.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active tDCS stimulation

Group Type EXPERIMENTAL

SOOMA™ tDCS™

Intervention Type DEVICE

The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes

Placebo tDCS stimulation

Group Type PLACEBO_COMPARATOR

SOOMA™ tDCS™

Intervention Type DEVICE

The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes

Interventions

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SOOMA™ tDCS™

The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age from 18 to 80 years,
* Sedated patient requiring mechanical ventilation for at least 48 hours with administration of morphine.
* Person affiliated to the social security system or beneficiary of an assimilated regime.
* RASS ≤ -2
* Close consent or emergency inclusion

Exclusion Criteria

* History of epilepsy.
* Severe brain injury (head trauma, stroke, neuromeningeal infection, status epilepticus).
* Presence of intracranial ferromagnetic material.
* Presence of electronic stimulators or implants (e.g. pacemaker, spinal cord or intracranial stimulator).
* Facial trauma preventing eye opening.
* Patients who are blind and/or have eye damage.
* Protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under legal protection.
* Subjects excluded from another study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No