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Nonverbal Communication in Aged People (MAMUS)

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music Balance Board
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease focused on measuring Music, Communication, Emotion, Behavior, Neurodegeneration disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Hôpital les Bateliers, CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with neurodegenerative disease

People with no neuropathological disease

Arm Description

Patients with neurodegenerative disease (AD or related disease)

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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)
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)
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)
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)
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.
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
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.
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.
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.
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)
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.
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.
Concentration of cortisol from saliva samples
measure the saliva cortisol before and after the synchronization task

Full Information

First Posted
January 9, 2019
Last Updated
November 19, 2020
Sponsor
University Hospital, Lille
Collaborators
France Alzheimer
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1. Study Identification

Unique Protocol Identification Number
NCT04146688
Brief Title
Nonverbal Communication in Aged People
Acronym
MAMUS
Official Title
Nonverbal Communication in Aged People With and Without Neurodegenerative Disease: Study of Sensorimotor Synchronization to Music
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
France Alzheimer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Music, Communication, Emotion, Behavior, Neurodegeneration disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with neurodegenerative disease
Arm Type
Active Comparator
Arm Description
Patients with neurodegenerative disease (AD or related disease)
Arm Title
People with no neuropathological disease
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Music Balance Board
Intervention Description
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.
Primary Outcome Measure Information:
Title
measure of consistency (oppositive of variability)
Description
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.
Time Frame
Baseline, before SMS task
Title
measure of asynchrony.
Description
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
Time Frame
Baseline, before SMS task
Secondary Outcome Measure Information:
Title
Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a real experimenter
Description
measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)
Time Frame
Baseline, before SMS task
Title
Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a virtual experimenter;
Description
measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)
Time Frame
after SMS task, an average after 45 min
Title
Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a real experimenter
Description
measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)
Time Frame
after SMS task, an average after 45 min
Title
Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a virtual experimenter.
Description
measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)
Time Frame
after SMS task, an average after 45 min
Title
Decoding of non-verbal behaviors during the synchronization task
Description
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.
Time Frame
after SMS task, an average after 45 min
Title
Intensity of body movements (quantity of motion)
Description
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
Time Frame
after SMS task, an average after 45 min
Title
STAI Anxiety Scale Score
Description
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.
Time Frame
through study completion, an average of 2 hours
Title
Decoding of the frequency (number of behaviors / duration of the condition) of the facial expressions
Description
the facial expressions based on videoscopic recordings of the synchronization task and a short interview (5min) by blind evaluators of the home group.
Time Frame
through study completion, an average of 2 hours
Title
Scale of Assessment of Daily Activities
Description
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.
Time Frame
through study completion, an average of 2 hours
Title
Scale of Instrumental Activities of Daily Living
Description
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)
Time Frame
through study completion, an average of 2 hours
Title
Neuropsychiatric Inventory (NPI) subscales Impact on the workload of the caregiver.
Description
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.
Time Frame
through study completion, an average of 2 hours
Title
mini-mental state examination (MMSE) score
Description
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.
Time Frame
through study completion, an average of 2 hours
Title
Concentration of cortisol from saliva samples
Description
measure the saliva cortisol before and after the synchronization task
Time Frame
Once, at Day 1, baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Puissieux, MD,PhD
Phone
3.20.44.46.02
Ext
+33
Email
francois.puisieux@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Puissieux, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital les Bateliers, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Puisieux, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Nonverbal Communication in Aged People

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