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

Neurophysiologic Abnormality Clinical Trial

— EXPRESONREA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798508
• Other study ID #: 2020-A00747-32
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: January 2021
• Source: Centre Hospitalier St Anne
• Contact: Estelle Pruvost-Robieux, MD
• Phone: + 33 1 45 65 81 89
• Email: e.pruvost[@]ghu-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: October 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coma
• Comatose
• Neurophysiologic Abnormality

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	GHU Paris Psychiatrie Neurosciences	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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	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
Primary	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	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
Primary	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	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
Secondary	Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale	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
Secondary	Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale	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
Secondary	Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale	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
Secondary	Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale	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
Secondary	Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening	Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Secondary	Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening	Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Secondary	Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening	Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Secondary	Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening	Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Secondary	Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.	Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices	3 months
Secondary	Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.	Latencies of P3a waves recorded with own name uttered by expressive and neutral voices	3 months