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NCT Number: NCT06179199

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

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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Key information

Conditions

Transcranial Direct Current Stimulation (tDCS) Agnosia Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Management Center - Chuga

Grenoble, France

Location contact

BEHOUCHE Alexandre, Doctor

SUB_INVESTIGATOR

HODAJ HASAN, Doctor

CONTACT

[email protected]

+33476765213

HODAJ Hasan, Doctor

PRINCIPAL_INVESTIGATOR

TROUVE BUISSON Thibaut, Doctor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SOOMA™ tDCS™

Device

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

Primary outcomes

  1. Pupillary Pain Index measurement

    Time frame: From Day1 to Day 4

    Measurement of the Pupillary Pain Index before and at the end of the tDCS stimulation session in both groups (active stimulation or placebo)

Secondary outcomes

  1. Comparison between groups of daily consumption of analgesics and sedatives

    Time frame: From Day1 to Day 4

  2. Inter-group comparison of changes in Behavioral Pain Scale score during painful care (tracheal suctioning)

    Time frame: From Day1 to Day 4

  3. Inter-group comparison of variations in pupil diameter measured by quantitative pupillometry in response to painful care (tracheal suctioning).

    Time frame: From Day1 to Day 4

  4. Inter-group comparison of changes in sedation levels measured by the Richmond Agitation-Sedation Scale

    Time frame: From Day1 to Day 4

  5. Inter-group comparison of the proportion of patients with a reduction in the Pupillary Pain Index ≥2 from baseline at the end of treatment.

    Time frame: From Day1 to Day 4

Study contacts

Contact information is provided by the study sponsor or research team.

HODAJ Hasan, DOCTOR

CONTACT

[email protected]

00330476765213

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: REASTIM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2023
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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