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

NCT04798508 | Unknown

• 1 other identifier: 2020-A00747-32
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Comatose; Neurophysiologic Abnormality

Keywords

DOC patients; ERP (Event related Potentials); Consciousness

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (10)

• Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices 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

  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

  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

  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

  3 months

Study Arms (1)

Whole group

OTHER

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

Other: Evoked related potential - P3 paradigm

Interventions

Evoked related potential - P3 paradigm OTHER

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

Whole group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Psychiatrie Neurosciences

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Estelle Pruvost-Robieux, MD

CONTACT

+ 33 1 45 65 81 89; e.pruvost@ghu-paris.fr

Martine Gavaret, Professor

CONTACT

+ 33 1 45 65 81 89; m.gavaret@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open and prospective study. Evoked related potentials are recorded for each participant while they listen 3 paradigms successively and in a random order: i) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: July 30, 2020
• Primary Completion: July 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-01

Locations

FR (1)