Beneficial Effects of Music on Cognition and Consciousness Level

Coma Clinical Trial

— MUSICOREVEIL  

Official title:

Beneficial Effects of Music on Cognition and Consciousness Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742506
• Other study ID #: 2012.750
• Secondary ID: 2012-A01025-38
• Status: Completed
• Phase: N/A
• Start date: June 25, 2013
• Est. completion date: October 23, 2019

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coma

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer - Service de Médecine Physique et Réadaptation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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