Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study is to determine if the use of emotional sound as subject own name (SON) pronounced by a familiar voice (FV) compared to SON pronounced by a non-familiar voice (NFV) during event related potential (ERP) produced a more reliable neurophysiological P300 responses, and to assess the prognostic value of this P300 responses induced by the SON with a FV.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage or head trauma,

persistent disorder of consciousness (DoC) 12 hours after sedation weaning or patient who has benefited from a prognostic assessment for persistent DoC and who has had in this assessment an evaluation by late PEA with MMN and P300 responses only to neutral sounds ("beep" and patient's first name pronounced by an unfamiliar voice) there is more than 6 months (since April 2022)

Disqualifiers

Moribund patient

Uncontrolled Shock during the neurophysiological evaluation

Sedated patient

Minor patient

Trial population

All patients admitted to Cochin Hospital ICU with a primary brain injury (after CA, TBI, stroke) and a persistent DOC (coma, VS, MCS) 12 hours after sedation discontinuation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Use of "expressive" sounds

    Other intervention

    Use of "expressive" sounds, that is to say the own first name pronounced by the voice of the relative to generate the P300 and a sound with an "approaching" character of the subject to generate the MMN. The investigators will thus be able to compare: * MMN: present/absent for each modality (neutral vs approaching sounds) * Wave P3a: latencies and amplitudes for each modality (own first name voice of the near vs unfamiliar).

  • Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)

    Other intervention

    Retrospective inclusion Have already had an assessment with event related potentials without "emotional" modalities (VF and similar sounds) as part of their care between April 2022 and December 2022 in intensive care at Cochin hospital.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Disorder of consciousness patients - Prospective group1 intervention
Group B: Disorder of consciousness patients - Retrospective group1 intervention

Trial outcomes

Primary outcomes

1

Glasgow Outcome Scale-Extended (GOS-E)

Neurological outcome - From 1 to 8 : 8 = Good Recovery - higher level / 7 = Good Recovery - lower level / 6 = Moderate disability - higher level / 5 = Moderate disability - lower level / 4 = Severe disability - higher level / 3 l= Severe disability - lower level / 2 = Persistent vegetative state / 1 = Death

Time frame
Month 3

Secondary outcomes

1

Glasgow coma scale (GCS)

Level of awareness - From 3 to 15 : Score of 3 to 8 defined comatose state, score 9 to 14 defined alteration of awareness or confusion and score 15 defined conscious and not confuse patients

Time frame
Day 7
2

Glasgow coma scale (GCS)

Level of awareness - From 3 to 15 : Score of 3 to 8 defined comatose state, score 9 to 14 defined alteration of awareness or confusion and score 15 defined conscious and not confuse patients

Time frame
Day 14
3

Richmond Agitation-Sedation Scale

Level of awareness - From -5 to + 4 : +4 = Combative Overtly combative, violent, immediate danger to staff / +3 = Very agitated Pulls or removes tube(s) or catheter(s); aggressive / +2 = Agitated Frequent non-purposeful movement, fights ventilator / +1 = Restless Anxious but movements not aggressive vigorous / 0 = Alert and calm / -1 = Drowsy Not fully alert, but has sustained awakening / (eye-opening/eye contact) to voice (\>10 seconds) / -2 = Light sedation Briefly awakens with eye contact to voice (\<10 seconds) / -3 = Moderate sedation Movement or eye opening to voice (but no eye contact) / -4 = Deep sedation No response to voice, but movement or eye opening to physical stimulation / -5 = Unarousable

Time frame
Day 7
4

Richmond Agitation-Sedation Scale

Level of awareness - From -5 to + 4 : +4 = Combative Overtly combative, violent, immediate danger to staff / +3 = Very agitated Pulls or removes tube(s) or catheter(s); aggressive / +2 = Agitated Frequent non-purposeful movement, fights ventilator / +1 = Restless Anxious but movements not aggressive vigorous / 0 = Alert and calm / -1 = Drowsy Not fully alert, but has sustained awakening / (eye-opening/eye contact) to voice (\>10 seconds) / -2 = Light sedation Briefly awakens with eye contact to voice (\<10 seconds) / -3 = Moderate sedation Movement or eye opening to voice (but no eye contact) / -4 = Deep sedation No response to voice, but movement or eye opening to physical stimulation / -5 = Unarousable

Time frame
Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator