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Beneficial Effects of Music on Cognition and Consciousness Level (MUSICOREVEIL)

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Civil Hospices of Lyon

Status

Completed

Conditions

Coma

Treatments

Other: Electroencephalography (EEG)

Study type

Interventional

Funder types

Other

Identifiers

NCT02742506
2012-A01025-38 (Other Identifier)
2012.750

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

Brain-damaged patients
Experimental group
Description:
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
Treatment:
Other: Electroencephalography (EEG)
Healthy volunteers
Active Comparator group
Description:
Electroencephalography (EEG) will be performed in healthy participants to assess the P300 response and medial prefrontal cortex activity after different auditive stimulations
Treatment:
Other: Electroencephalography (EEG)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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