Clinical trial NCT04146688: Nonverbal Communication in Aged People
Official title: Nonverbal Communication in Aged People With and Without Neurodegenerative Disease: Study of Sensorimotor Synchronization to Music
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Music
Communication
Emotion
Behavior
Neurodegeneration disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: France Alzheimer
First posted: 2019-10-31
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Musical interventions improve the emotional state of patients with Alzheimer's disease (AD) while having a positive impact on the caregiver's well-being. However, the factors that could be responsible for this positive effect remain unknown. Among these, the sensory-motor synchronization (SMS) of movements to the musical rhythm, frequently observed during musical activities and possible up to the advanced stages of AD, could modulate the emotional state. Several recent studies have shown that rhythmic training (or SMS) influences the organism at the motor, cognitive and social levels while activating the cerebral reward circuit. This action that generates pleasure also facilitates non-verbal emotional expression. However, the conditions that modulate SMS and their relationship to nonverbal communication, emotional, behavioral and cognitive state have not yet been studied in healthy or pathological elderly.


Eligibility criteria: Inclusion Criteria:

Cases : Patients with neurodegenerative disease (AD or related disease)

* Native French Language
* Corrected auditory and/or visual deficiency
* Right-handed
* Image rights consent signed by the patient Controls: People with no neuropathological disease
* Native French Language
* Corrected auditory and/or visual deficiency
* Right-handed
* Image rights consent signed by the control

Exclusion Criteria:

-

Primary outcomes:
measure: measure of consistency (oppositive of variability)
timeFrame: Baseline, before SMS task
measure: measure of asynchrony.
timeFrame: Baseline, before SMS task
Secondary outcomes:
measure: Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a real experimenter
timeFrame: Baseline, before SMS task
measure: Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a virtual experimenter;
timeFrame: after SMS task, an average after 45 min
measure: Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a real experimenter
timeFrame: after SMS task, an average after 45 min
measure: Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a virtual experimenter.
timeFrame: after SMS task, an average after 45 min
measure: Decoding of non-verbal behaviors during the synchronization task
timeFrame: after SMS task, an average after 45 min
measure: Intensity of body movements (quantity of motion)
timeFrame: after SMS task, an average after 45 min
measure: STAI Anxiety Scale Score
timeFrame: through study completion, an average of 2 hours
measure: Decoding of the frequency (number of behaviors / duration of the condition) of the facial expressions
timeFrame: through study completion, an average of 2 hours
measure: Scale of Assessment of Daily Activities
timeFrame: through study completion, an average of 2 hours
measure: Scale of Instrumental Activities of Daily Living
timeFrame: through study completion, an average of 2 hours
measure: Neuropsychiatric Inventory (NPI) subscales Impact on the workload of the caregiver.
timeFrame: through study completion, an average of 2 hours
measure: mini-mental state examination (MMSE) score
timeFrame: through study completion, an average of 2 hours
measure: Concentration of cortisol from saliva samples
timeFrame: Once, at Day 1, baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital les Bateliers, CHU
Study officials:
affiliation: University Hospital, Lille
name: François Puissieux, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: