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Completed

NCT Number: NCT04146688

Nonverbal Communication in Aged People

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.

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Key information

Conditions

Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Communication Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital les Bateliers, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Music Balance Board

Other

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 outcomes

  1. measure of consistency (oppositive of variability)

    Time frame: Baseline, before SMS task

    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.

  2. measure of asynchrony.

    Time frame: Baseline, before SMS task

    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 outcomes

  1. Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a real experimenter

    Time frame: Baseline, before SMS task

    measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)

  2. Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a virtual experimenter;

    Time frame: after SMS task, an average after 45 min

    measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)

  3. Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a real experimenter

    Time frame: after SMS task, an average after 45 min

    measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)

  4. Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a virtual experimenter.

    Time frame: after SMS task, an average after 45 min

    measure the quantity of movements derived from the variation of weight on the sensors below the platform in millivolts (mV)

  5. Decoding of non-verbal behaviors during the synchronization task

    Time frame: after SMS task, an average after 45 min

    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.

  6. Intensity of body movements (quantity of motion)

    Time frame: after SMS task, an average after 45 min

    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

  7. STAI Anxiety Scale Score

    Time frame: through study completion, an average of 2 hours

    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.

  8. Decoding of the frequency (number of behaviors / duration of the condition) of the facial expressions

    Time frame: through study completion, an average of 2 hours

    the facial expressions based on videoscopic recordings of the synchronization task and a short interview (5min) by blind evaluators of the home group.

  9. Scale of Assessment of Daily Activities

    Time frame: through study completion, an average of 2 hours

    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.

  10. Scale of Instrumental Activities of Daily Living

    Time frame: through study completion, an average of 2 hours

    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)

  11. Neuropsychiatric Inventory (NPI) subscales Impact on the workload of the caregiver.

    Time frame: through study completion, an average of 2 hours

    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.

  12. mini-mental state examination (MMSE) score

    Time frame: through study completion, an average of 2 hours

    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.

  13. Concentration of cortisol from saliva samples

    Time frame: Once, at Day 1, baseline

    measure the saliva cortisol before and after the synchronization task

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • France Alzheimer

Registry information

Official study title

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

Acronym: MAMUS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2019
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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