Clinical trial NCT02742506: Beneficial Effects of Music on Cognition and Consciousness Level
Official title: Beneficial Effects of Music on Cognition and Consciousness Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coma
Keywords: Brain-damaged
Disorders of consciousness
Post-coma
consciousness
coma
vegetative state
minimally conscious state
music
P300
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: P300 response in brain-damaged patients
timeFrame: 24 hours after inclusion
Secondary outcomes:
measure: P300 response in healthy volunteers
timeFrame: 24 hours after inclusion
measure: P300 response in brain-damaged patients
timeFrame: 24 hours after inclusion
measure: Medial prefrontal cortex activity level in healthy volunteers
timeFrame: 24 hours after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer - Service de Médecine Physique et Réadaptation
Study officials:
References: