Beneficial Effects of Music on Cognition and Consciousness Level

Study Overview
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Brief Summary
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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.

Official Title
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Beneficial Effects of Music on Cognition and Consciousness Level

Conditions
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Coma

Intervention / Treatment
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* Other: Electroencephalography (EEG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain-damaged patients<br>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)<br>* 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<br>|
| Active Comparator: Healthy volunteers<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P300 response in brain-damaged patients | 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. | 24 hours after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P300 response in healthy volunteers | 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) | 24 hours after inclusion | 
| P300 response in brain-damaged patients | 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). | 24 hours after inclusion | 
| Medial prefrontal cortex activity level in healthy volunteers | 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). | 24 hours after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, Brain-damaged, Disorders of consciousness, Post-coma, consciousness, coma, vegetative state, minimally conscious state, P300