Nonverbal Communication in Aged People

Alzheimer Disease Clinical Trial

— MAMUS  

Official title:

Nonverbal Communication in Aged People With and Without Neurodegenerative Disease: Study of Sensorimotor Synchronization to Music

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146688
• Other study ID #: 2017_35
• Secondary ID: 2017-A03543-50
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: May 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: François Puissieux, MD,PhD
• Phone: 3.20.44.46.02
• Email: francois.puisieux[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Music Balance Board
The SSM is measured with an innovative tool (Music Balance Board) developed at the University of Ghent (Belgium) and specially designed to record the movements of the elderly in a natural and comfortable position This chair is equipped with a tablet and sensors that record the movements of the hand and body during the SSM to a musical sequence. The analysis will focus on the difference between the participant's striking and the beat of the music measured using this chair.

Locations

Country	Name	City	State
France	Hôpital les Bateliers, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Fondation France Alzheimer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of consistency (oppositive of variability)	measure of consistency (oppositive of variability) of the response corresponding to the length of a vector going from 0 (bad) to 1(very good response).; This measure is completed by another measure of asynchrony.	Baseline, before SMS task
Primary	measure of asynchrony.	The asynchrony assess the accuracy of the movements in ms. If the participant anticipated the tap relative to the musical beat, the value is negative, if the participant delayed the tap, the value is positive. A perfect tap is 0 in this case	Baseline, before SMS task
Secondary	Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a real experimenter	measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)	Baseline, before SMS task
Secondary	Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a virtual experimenter;	measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)	after SMS task, an average after 45 min
Secondary	Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a real experimenter	measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)	after SMS task, an average after 45 min
Secondary	Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a virtual experimenter.	measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)	after SMS task, an average after 45 min
Secondary	Decoding of non-verbal behaviors during the synchronization task	Decoding of non-verbal behavior during the synchronization task (rhythmic movements of the head, lips and lower limbs, visual contact) in duration (duration of the behavior/duration of the Condition expressed in seconds) by blind evaluators in the membership group.	after SMS task, an average after 45 min
Secondary	Intensity of body movements (quantity of motion)	Intensity of body movements (quantity of motion) recorded by the motion sensors connected to the chair on which the patient sits.; recorded during the SSM test and a filmed interview	after SMS task, an average after 45 min
Secondary	STAI Anxiety Scale Score	The State-Trait Anxiety Inventory (STAI) is a self-questionnaire, developed by Spielberger (7) and validated in French. It has 20 questions, assessing the subject's usual emotional state. A score is calculated, ranging from 20 to 80, a high score indicating the presence of anxiety.	through study completion, an average of 2 hours
Secondary	Decoding of the frequency (number of behaviors / duration of the condition) of the facial expressions	the facial expressions based on videoscopic recordings of the synchronization task and a short interview (5min) by blind evaluators of the home group.	through study completion, an average of 2 hours
Secondary	Scale of Assessment of Daily Activities	The ADLs used measure of functional ability is the Katz Activities of Daily Living Scale (Katz et al., 1963; Katx, 1983). In this scale, the set of tasks assessed are bathing, dressing, transferring, using the toilet, continence, and eating.	through study completion, an average of 2 hours
Secondary	Scale of Instrumental Activities of Daily Living	The Lawton IADL Scale takes approximately 10 to 15 minutes to administer. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning)	through study completion, an average of 2 hours
Secondary	Neuropsychiatric Inventory (NPI) subscales Impact on the workload of the caregiver.	total NPI score is defined as the sum of the individual category scores. Higher scores on NPI indicate a more frequent and/or severe presence of neuropsychiatric behavioral changes. The following domains will be included in the subscore: Depression/Dysphoria, Anxiety, Apathy/Indifference, Irritability/Lability, Agitation/Aggression, and Disinhibition.	through study completion, an average of 2 hours
Secondary	mini-mental state examination (MMSE) score	The Mini-Mental State Examination (MMSE) is a brief 30-point questionnaire test that is used to screen for cognitive impairment.; Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.	through study completion, an average of 2 hours
Secondary	Concentration of cortisol from saliva samples	measure the saliva cortisol before and after the synchronization task	Once, at Day 1, baseline