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

15. mars 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

78

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Paris, Frankrike, 75014
        • Rekruttering
        • GHU Paris Psychiatrie Neurosciences
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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
Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier St Anne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juli 2020

Primær fullføring (Forventet)

30. juli 2022

Studiet fullført (Forventet)

30. oktober 2022

Datoer for studieregistrering

Først innsendt

5. mars 2021

Først innsendt som oppfylte QC-kriteriene

12. mars 2021

Først lagt ut (Faktiske)

15. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2020-A00747-32

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