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CompletedNCT02742506MUSICOREVEILUpdated Sep 3, 2025

Beneficial Effects of Music on Cognition and Consciousness Level

An interventional study of Electroencephalography (EEG) in Coma, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jun 2013, registered Apr 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coma

Keywords

  • Brain-damaged
  • Disorders of consciousness
  • Post-coma
  • consciousness
  • coma
  • vegetative state
  • minimally conscious state
  • music
  • P300
03

In context

Coma

138 studies on the registry are indexed under Coma; 35 are open to participants now.

This study's enrollment of 86 is close to the median of 85 across 77 interventional studies indexed under Coma.

Browse Coma studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • OtherElectroencephalography (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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours after inclusion

Secondary outcomes

  1. 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)

    Time frame: 24 hours after inclusion

  2. 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).

    Time frame: 24 hours after inclusion

  3. 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).

    Time frame: 24 hours after inclusion

07

Study locations

1 site
  • Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer - Service de Médecine Physique et Réadaptation
    Lyon, 69500, France
08

References and documents

Publications

  • Heine L, Corneyllie A, Gobert F, Luaute J, Lavandier M, Perrin F. Virtually spatialized sounds enhance auditory processing in healthy participants and patients with a disorder of consciousness. Sci Rep. 2021 Jul 1;11(1):13702. doi: 10.1038/s41598-021-93151-6. PubMed 34211035 ↗
  • Castro M, Tillmann B, Luaute J, Corneyllie A, Dailler F, Andre-Obadia N, Perrin F. Boosting Cognition With Music in Patients With Disorders of Consciousness. Neurorehabil Neural Repair. 2015 Sep;29(8):734-42. doi: 10.1177/1545968314565464. Epub 2015 Feb 3. PubMed 25650390 ↗
  • Corneyllie A, Perrin F, Heine L. Sharing an Open Stimulation System for Auditory EEG Experiments Using Python, Raspberry Pi, and HifiBerry. eNeuro. 2021 Aug 25;8(4):ENEURO.0524-20.2021. doi: 10.1523/ENEURO.0524-20.2021. Print 2021 Jul-Aug. PubMed 34301720 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2013 to primary completion in Oct 2019, 75 months.

Of 39 non-industry interventional studies with no phase under Coma, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's 75 months is above that.

Counting every sponsor, half of 39 studies reached it within 39 months; a quarter within 17 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2016
First posted
Apr 19, 2016
StartActual
Jun 25, 2013
Primary completionActual
Oct 23, 2019
CompletionActual
Oct 23, 2019
Last update
Sep 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02742506
Responsible party
Sponsor
First posted
Apr 19, 2016
Start date
Jun 25, 2013
Primary completion
Oct 23, 2019
Completion
Oct 23, 2019
Last update
Sep 3, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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