MUSICOREVEIL: Beneficial Effects of Music on Cognition and Consciousness Level

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02742506

Collaborator

(none)

Enrollment

Location

Arms

75.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged patients. However, it is still difficult to understand what precisely in music causes a positive effect : are they emotional components, familiarity or preference which improve cognition or is there any specific effect of music? Moreover, it is not yet possible to characterize the neural and functional links between the brain systems solicited by music and those associated with other cognitive functions enhanced by music.

Finally, researches on brain-damaged patients have not exploited the potential effect of music on the level of alert and perceptual awareness, while this type of stimulation could be a valuable tool to improve cognition in patients with a disturbance of consciousness and alertness.

The main objective is to describe the impact of music on the brain's response to self-referential or neutral stimuli in brain-damaged patients with persistent consciousness disorder after a coma and in healthy participants.

Condition or Disease	Intervention/Treatment	Phase
Coma	Other: Electroencephalography (EEG)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Beneficial Effects of Music on Cognition and Consciousness Level

Actual Study Start Date :

Jun 25, 2013

Actual Primary Completion Date :

Oct 23, 2019

Actual Study Completion Date :

Oct 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain-damaged patients Electroencephalography (EEG) will be performed in patients in coma, in a vegetative state or in a minimally conscious state to assess the P300 response after different auditive stimulations	Other: Electroencephalography (EEG) EEG will be performed to assess brain activity in response to sounds of different nature, including music and the given name of the registered person
Active Comparator: Healthy volunteers Electroencephalography (EEG) will be performed in healthy participants to assess the P300 response and medial prefrontal cortex activity after different auditive stimulations	Other: Electroencephalography (EEG) EEG will be performed to assess brain activity in response to sounds of different nature, including music and the given name of the registered person

Arm

Intervention/Treatment

Experimental: Brain-damaged patients

Electroencephalography (EEG) will be performed in patients in coma, in a vegetative state or in a minimally conscious state to assess the P300 response after different auditive stimulations

Other: Electroencephalography (EEG)

EEG will be performed to assess brain activity in response to sounds of different nature, including music and the given name of the registered person

Active Comparator: Healthy volunteers

Electroencephalography (EEG) will be performed in healthy participants to assess the P300 response and medial prefrontal cortex activity after different auditive stimulations

Other: Electroencephalography (EEG)

EEG will be performed to assess brain activity in response to sounds of different nature, including music and the given name of the registered person

Outcome Measures

Primary Outcome Measures

P300 response in brain-damaged patients [24 hours after inclusion]
Improvement of the P300 response (increase in amplitude and / or a decrease in latency) to the first name pronunciation will be assessed in patients in coma, in a vegetative state or in a minimally conscious state, when it is preceded by a favorite or familiar sound (music, language, environmental noise) and / or a positive emotional connotation, compared to a control condition (unfamiliar sound and / or neutral emotional connotation). This improvement in brain response will be the sign of a more efficient categorization of patient's own name.

Secondary Outcome Measures

P300 response in healthy volunteers [24 hours after inclusion]
Improvement of the P300 response (increase in amplitude and / or a decrease in latency) to a self-referential stimulation (eg first name pronunciation) compared to a non-self-referential stimulation (eg other name) will be assessed in healthy participants when it is preceded by a favorite or familiar sound (music, language, environmental noise) and / or a positive emotional connotation, compared to a control condition (sound unfamiliar and / or neutral emotional connotation)
P300 response in brain-damaged patients [24 hours after inclusion]
Increase of the P300 response (increase in amplitude and / or a decrease in latency) to a self-referential stimulation (e.g. name pronunciation) will be assessed when the patient is awake (according to EEG measures and / or eye opening) compared to when the patient is asleep (according to EEG measures and / or eye closure).
Medial prefrontal cortex activity level in healthy volunteers [24 hours after inclusion]
Increase of the level of activity measured in the medial prefrontal cortex will be assessed in healthy participants after a favorite or familiar sound (music, language, environmental noise) and / or a positive emotional connotation, compared to a control condition (unfamiliar sound and / or neutral emotional connotation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Brain-damaged patients :

Inclusion Criteria:

Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
Lack of autonomic crisis since one week minimum
Medical condition considered stable
Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

Exclusion Criteria:

Hearing Problem
Uncontrolled Epilepsy
Autonomic crises
Medical unstable state
Pregnant or likely to be (interrogation data) or breastfeeding woman

Healthy participants :

Inclusion Criteria:

Subjects with normal hearing
Absence of neurological disorder
Subjects able to understand the experimental instructions

Exclusion Criteria:

Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
Neurological disorders
Pregnant or likely to be (interrogation data) or breastfeeding woman