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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transcranial Direct Current Stimulation (tDCS)
• Intervention / Treatment: Device: SOOMA™ tDCS™

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HODAJ Hasan, DOCTOR; Phone Number: 00330476765213; Email: HHodaj@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Pain Management Center - Chuga
    • Contact: HODAJ HASAN, Doctor; Phone Number: +33476765213; Email: HHodaj@chu-grenoble.fr
    • Principal Investigator: HODAJ Hasan, Doctor
    • Sub-Investigator: TROUVE BUISSON Thibaut, Doctor
    • Sub-Investigator: BEHOUCHE Alexandre, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Chronic pain; Pain management; Intensive care unit; Transcranial direct current stimulation (tDCS); Sedated patient; Analgesic therapy
• Other Study ID Numbers: 38RC23.0217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No