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

Nog niet rekruterend
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De klinische studie NCT06179199 (REASTIM) is een interventioneel studie bij Transcraniële gelijkstroomstimulatie (tDCS) met de status nog niet rekruterend. De inclusie van 40 deelnemers start op 1 oktober 2024. De studie wordt geleid door University Hospital, Grenoble en de voltooiing is gepland op 1 december 2025. Laatste update op ClinicalTrials.gov: 19 september 2024.
Beknopte samenvatting
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.

Officiële titel

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

Aandoeningen
Transcraniële gelijkstroomstimulatie (tDCS)
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • REASTIM
  • 38RC23.0217
NCT-ID
Startdatum (Werkelijk)
2024-10
Laatste update geplaatst
2024-09-19
Verwachte einddatum
2025-12
Inschrijving (Geschat)
40
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
Pain management
Transcranial direct current stimulation (tDCS)
Analgesic therapy
Chronic pain
Sedated patient
Intensive care unit
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelActive tDCS stimulation
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-comparatorPlacebo tDCS stimulation
SOOMA™ TDCS™
The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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

  • 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.
University Hospital, Grenoble logoUniversity Hospital, Grenoble
Centraal Contactpersoon
Contact: HODAJ Hasan, DOCTOR, 00330476765213, [email protected]
1 Studielocaties in 1 landen
Pain Management Center - Chuga, Grenoble, France
HODAJ HASAN, Doctor, Contact, +33476765213, [email protected]
HODAJ Hasan, Doctor, Hoofdonderzoeker
TROUVE BUISSON Thibaut, Doctor, Subonderzoeker
BEHOUCHE Alexandre, Doctor, Subonderzoeker