NCT02742506

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2019

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6.3 years

First QC Date

April 7, 2016

Last Update Submit

August 26, 2025

Conditions

Keywords

Brain-damagedDisorders of consciousnessPost-comaconsciousnesscomavegetative stateminimally conscious statemusicP300

Outcome Measures

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.

    24 hours after inclusion

Secondary Outcomes (3)

  • P300 response in healthy volunteers

    24 hours after inclusion

  • P300 response in brain-damaged patients

    24 hours after inclusion

  • Medial prefrontal cortex activity level in healthy volunteers

    24 hours after inclusion

Study Arms (2)

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

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

Other: Electroencephalography (EEG)

Interventions

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

Brain-damaged patientsHealthy volunteers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hearing Problem
  • Uncontrolled Epilepsy
  • Autonomic crises
  • Medical unstable state
  • Pregnant or likely to be (interrogation data) or breastfeeding woman
  • Healthy participants :
  • Subjects with normal hearing
  • Absence of neurological disorder
  • Subjects able to understand the experimental instructions
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69500, France

Location

Related Publications (3)

  • 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.

    PMID: 34301720BACKGROUND
  • 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.

    PMID: 34211035BACKGROUND
  • 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.

    PMID: 25650390BACKGROUND

MeSH Terms

Conditions

ComaConsciousness DisordersPersistent Vegetative State

Condition Hierarchy (Ancestors)

UnconsciousnessNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 19, 2016

Study Start

June 25, 2013

Primary Completion

October 23, 2019

Study Completion

October 23, 2019

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations