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EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients (EXPRESONREA)

15. marts 2021 opdateret af: Centre Hospitalier St Anne

EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.

Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.

Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.

Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient. However the correlation of this P3 wave and neurologic prognosis is still imperfect and depends on the etiology of the DOC.

In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices involves more widespread brain areas than neutral voices processing.

Here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. The investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

78

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Paris, Frankrig, 75014
        • Rekruttering
        • GHU Paris Psychiatrie Neurosciences
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age over 18
  • Disorder of consciousness defined as :

Glasgow coma scale < 8 or >8 but

  • eyes opening to pain only
  • No response to basic command
  • Available neuro-imagery (CT-scan or MRI)
  • Normal temperature (no fever or hypothermia)
  • Normal blood pressure during neurophysiologic evaluation
  • Given consent from relatives

Exclusion Criteria:

  • Brain death
  • Known deafness
  • Severe sepsis uncontrolled during neurophysiologic evaluation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Whole group

The whole group listen successively the 3 paradigms :

  • P3 own-name recorded by listening to a smiling voice
  • P3 own-name recorded by listening to a neutral voice
  • P3 own-name recorded by listening to a rough voice
Andet: Evoked related potential - P3 paradigm
Evoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months
Tidsramme: 3 months from DOC evaluation
Determination of the positive predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
3 months from DOC evaluation
Negative predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Tidsramme: 3 months from DOC evaluation
Determination of the negative predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
3 months from DOC evaluation
Sensitivity of P3a responses occurences to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Tidsramme: 3 months from DOC evaluation
Determination of the sensibility of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
3 months from DOC evaluation
Specificity of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Tidsramme: 3 months from DOC evaluation
Determination of the specificity of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
3 months from DOC evaluation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Tidsramme: 7, 14 and 28 days from DOC evaluation
Determination of the negative predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
7, 14 and 28 days from DOC evaluation
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Tidsramme: 7, 14 and 28 days from DOC evaluation
Determination of the positive predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
7, 14 and 28 days from DOC evaluation
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
Tidsramme: 7, 14 and 28 days from DOC evaluation
Determination of the sensibility of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
7, 14 and 28 days from DOC evaluation
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Tidsramme: 7, 14 and 28 days from DOC evaluation
Determination of the specificity of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
7, 14 and 28 days from DOC evaluation
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Tidsramme: 3 months
Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months
3 months
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Tidsramme: 3 months
Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months
3 months
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
Tidsramme: 3 months
Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months
3 months
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Tidsramme: 3 months
Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months
3 months
Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Tidsramme: 3 months
Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices
3 months
Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Tidsramme: 3 months
Latencies of P3a waves recorded with own name uttered by expressive and neutral voices
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier St Anne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juli 2020

Primær færdiggørelse (Forventet)

30. juli 2022

Studieafslutning (Forventet)

30. oktober 2022

Datoer for studieregistrering

Først indsendt

5. marts 2021

Først indsendt, der opfyldte QC-kriterier

12. marts 2021

Først opslået (Faktiske)

15. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020-A00747-32

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