ComaMUSICOREVEILNCT02742506
Beneficial Effects of Music on Cognition and Consciousness Level
A study testing Electroencephalography (EEG) in people with Coma, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coma
- What is being tested?
- Electroencephalography (EEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2013to 23 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Subjects with normal hearing
- Absence of neurological disorder
- Subjects able to understand the experimental instructions
Who cannot join
- Hearing Problem
- Uncontrolled Epilepsy
- Autonomic crises
- Medical unstable state
- Pregnant or likely to be (interrogation data) or breastfeeding woman
- Healthy participants :
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer - Service de Médecine Physique et Réadaptation
Lyon, 69500
About this study
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.
- Conditions
- Coma
- Being tested
- Electroencephalography (EEG)
- Keywords
- Brain-damaged, Disorders of consciousness, Post-coma, consciousness, coma, vegetative state, minimally conscious state, music, P300
- Medical subject headings
- Coma, Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Brain-damaged patients | Experimental | 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 Receives: Other: Electroencephalography (EEG) |
| Healthy volunteers | Active comparator | Electroencephalography (EEG) will be performed in healthy participants to assess the P300 response and medial prefrontal cortex activity after different auditive stimulations Receives: Other: Electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after inclusion
Secondary outcomes (3)
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)
Measured: 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).
Measured: 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).
Measured: 24 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start25 Jun 2013
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742506
- Sponsor's protocol ID
- 2012.750
- Other IDs
- 2012-A01025-38
- Acronym
- MUSICOREVEIL
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2016
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 34211035Castro 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 25650390Corneyllie 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Music on Cognition and Consciousness Level
- ClinicalTrials.gov ID
- NCT02742506
- Acronym / sponsor ID
- MUSICOREVEIL / 2012.750
- Conditions
- Coma
- Keywords
- Brain-damaged, Disorders of consciousness, Post-coma, consciousness, coma, vegetative state, minimally conscious state, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jun 2013 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain-damaged patients | Experimental | Other: Electroencephalography (EEG)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 |
| Healthy volunteers | Active comparator | Other: Electroencephalography (EEG)Electroencephalography (EEG) will be performed in healthy participants to assess the P300 response and medial prefrontal cortex activity after different auditive stimulations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- Hearing Problem
- Uncontrolled Epilepsy
- Autonomic crises
- Medical unstable state
- Pregnant or likely to be (interrogation data) or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Brain-damaged patients, Healthy volunteers |
Primary outcome
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.
3 secondary outcomes
P300 response in healthy volunteers
Time frame: 24 hours after inclusion
P300 response in brain-damaged patients
Time frame: 24 hours after inclusion
Medial prefrontal cortex activity level in healthy volunteers
Time frame: 24 hours after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 34211035Heine 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.
- Background: PubMed 25650390Castro 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.
- Results publication: PubMed 34301720Corneyllie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography (EEG) in people with Coma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P300 response in brain-damaged patients (time frame: 24 hours after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742506, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.