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Completed

NCT Number: NCT02742506

Beneficial Effects of Music on Cognition and Consciousness Level

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.

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Key information

Conditions

Coma Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer - Service de Médecine Physique et Réadaptation

Lyon, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroencephalography (EEG)

Other

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

Primary outcomes

  1. P300 response in brain-damaged patients

    Time frame: 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 outcomes

  1. P300 response in healthy volunteers

    Time frame: 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)

  2. P300 response in brain-damaged patients

    Time frame: 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).

  3. Medial prefrontal cortex activity level in healthy volunteers

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MUSICOREVEIL

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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