Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SOOMA™ tDCS™.
- Who it may be relevant to
- Registry conditions: Transcranial Direct Current Stimulation (tDCS). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- 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
Primary outcome measures
- Pupillary Pain Index measurement [Time frame: From Day1 to Day 4]
Secondary outcome measures (5)
- Comparison between groups of daily consumption of analgesics and sedatives [Time frame: From Day1 to Day 4]
- Inter-group comparison of changes in Behavioral Pain Scale score during painful care (tracheal suctioning) [Time frame: From Day1 to Day 4]
- 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]
- Inter-group comparison of changes in sedation levels measured by the Richmond Agitation-Sedation Scale [Time frame: 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. [Time frame: From Day1 to Day 4]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Pain Management Center - Chuga — Grenoble
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, C PMID 30113379
- 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 29952860
- 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 11801819
Identifiers
NCT: NCT06179199 · 38RC23.0217