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

Study Overview
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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.

Official Title
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Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.Randomized, Placebo-controlled, Double-blind Study.

Conditions
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Transcranial Direct Current Stimulation (tDCS)

Intervention / Treatment
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* Device: SOOMA™ tDCS™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 80 years, Sedated patient in stable condition requiring mechanical ventilation for at least 72 hours with continuous administration of morphine. Person affiliated to the social security system or beneficiary of an assimilated regime. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active tDCS stimulation ; Placebo tDCS stimulation.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS stimulation<br> | Device: SOOMA™ tDCS™<br>* The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes<br>|
| Placebo Comparator: Placebo tDCS stimulation<br> | Device: SOOMA™ tDCS™<br>* The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillary Pain Index measurement | Measurement of the Pupillary Pain Index before and at the end of the tDCS stimulation session in both groups (active stimulation or placebo) | From Day1 to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between groups of daily consumption of analgesics and sedatives |  | From Day1 to Day 4 | 
| Inter-group comparison of changes in Behavioral Pain Scale score during painful care (tracheal suctioning) |  | From Day1 to Day 4 | 
| Inter-group comparison of variations in pupil diameter measured by quantitative pupillometry in response to painful care (tracheal suctioning). |  | From Day1 to Day 4 | 
| Inter-group comparison of changes in sedation levels measured by the Richmond Agitation-Sedation Scale |  | From Day1 to Day 4 | 
| Inter-group comparison of the proportion of patients with a reduction in the Pupillary Pain Index ≥2 from baseline at the end of treatment. |  | From Day1 to Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Transcranial direct current stimulation (tDCS), Analgesic therapy, Chronic pain, Sedated patient, Intensive care unit