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

15 maart 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

78

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
      • Paris, Frankrijk, 75014
        • Werving
        • GHU Paris Psychiatrie Neurosciences
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 3 months
Latencies of P3a waves recorded with own name uttered by expressive and neutral voices
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier St Anne

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juli 2020

Primaire voltooiing (Verwacht)

30 juli 2022

Studie voltooiing (Verwacht)

30 oktober 2022

Studieregistratiedata

Eerst ingediend

5 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

12 maart 2021

Eerst geplaatst (Werkelijk)

15 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 maart 2021

Laatste update ingediend die voldeed aan QC-criteria

15 maart 2021

Laatst geverifieerd

1 januari 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2020-A00747-32

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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