NCT06179199

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

December 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

December 11, 2023

Last Update Submit

December 11, 2025

Conditions

Transcranial Direct Current Stimulation (tDCS)

Keywords

Pain managementTranscranial direct current stimulation (tDCS)Analgesic therapyChronic painSedated patientIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Active tDCS stimulation

EXPERIMENTAL
Device: SOOMA™ tDCS™

Placebo tDCS stimulation

PLACEBO COMPARATOR
Device: SOOMA™ tDCS™

Interventions

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

Active tDCS stimulationPlacebo tDCS stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Management Center - Chuga

Grenoble, France

Location

Related Publications (3)

  • Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

    PMID: 30113379BACKGROUND

  • Pinto CB, Teixeira Costa B, Duarte D, Fregni F. Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. J ECT. 2018 Sep;34(3):e36-e50. doi: 10.1097/YCT.0000000000000518.

    PMID: 29952860BACKGROUND

  • Payen JF, Bru O, Bosson JL, Lagrasta A, Novel E, Deschaux I, Lavagne P, Jacquot C. Assessing pain in critically ill sedated patients by using a behavioral pain scale. Crit Care Med. 2001 Dec;29(12):2258-63. doi: 10.1097/00003246-200112000-00004.

    PMID: 11801819BACKGROUND

MeSH Terms

Conditions

AgnosiaChronic Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Central Study Contacts

HODAJ Hasan, DOCTOR

CONTACT

00330476765213HHodaj@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: * Active tDCS stimulation ; * Placebo tDCS stimulation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 21, 2023

Study Start

January 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)