Alzheimer DiseaseMAMUSNCT04146688
Nonverbal Communication in Aged People
A study testing Music Balance Board in people with Alzheimer Disease, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Music Balance Board
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2018to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Corrected auditory and/or visual deficiency
- Right-handed
- Image rights consent signed by the control
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nonverbal Communication in Aged People With and Without Neurodegenerative Disease: Study of Sensorimotor Synchronization to Music
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.
- Conditions
- Alzheimer Disease
- Being tested
- Music Balance Board
- Keywords
- Music, Communication, Emotion, Behavior, Neurodegeneration disease
- Medical subject headings
- Alzheimer Disease, Communication, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Balance BoardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with neurodegenerative disease | Active comparator | Patients with neurodegenerative disease (AD or related disease) Receives: Other: Music Balance Board |
| People with no neuropathological disease | Active comparator | Not described Receives: Other: Music Balance Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, before SMS task
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
Measured: Baseline, before SMS task
Secondary outcomes (13)
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)
Measured: Baseline, before SMS task
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)
Measured: after SMS task, an average after 45 min
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)
Measured: after SMS task, an average after 45 min
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)
Measured: after SMS task, an average after 45 min
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.
Measured: after SMS task, an average after 45 min
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
Measured: after SMS task, an average after 45 min
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.
Measured: through study completion, an average of 2 hours
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.
Measured: through study completion, an average of 2 hours
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.
Measured: through study completion, an average of 2 hours
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)
Measured: through study completion, an average of 2 hours
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.
Measured: through study completion, an average of 2 hours
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.
Measured: through study completion, an average of 2 hours
Concentration of cortisol from saliva samples
measure the saliva cortisol before and after the synchronization task
Measured: Once, at Day 1, baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start17 May 2018
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- France Alzheimer
- Responsible party
- Sponsor
- Investigators
- François Puissieux, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146688
- Sponsor's protocol ID
- 2017_35
- Other IDs
- 2017-A03543-50
- Acronym
- MAMUS
- Status last verified
- Nov 2020
- First submitted
- 9 Jan 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonverbal Communication in Aged People With and Without Neurodegenerative Disease: Study of Sensorimotor Synchronization to Music
- ClinicalTrials.gov ID
- NCT04146688
- Acronym / sponsor ID
- MAMUS / 2017_35
- Conditions
- Alzheimer Disease
- Keywords
- Music, Communication, Emotion, Behavior, Neurodegeneration disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- France Alzheimer
- Study start
- 17 May 2018 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with neurodegenerative disease | Active comparator | Other: Music Balance BoardPatients with neurodegenerative disease (AD or related disease) |
| People with no neuropathological disease | Active comparator | Other: Music Balance Board |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Balance BoardThe 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. | Other | Patients with neurodegenerative disease, People with no neuropathological disease |
Primary outcome
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.
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
13 secondary outcomes
Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a real experimenter
Time frame: Baseline, before SMS task
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
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
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
Decoding of non-verbal behaviors during the synchronization task
Time frame: after SMS task, an average after 45 min
Intensity of body movements (quantity of motion)
Time frame: after SMS task, an average after 45 min
STAI Anxiety Scale Score
Time frame: through study completion, an average of 2 hours
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
Scale of Assessment of Daily Activities
Time frame: through study completion, an average of 2 hours
Scale of Instrumental Activities of Daily Living
Time frame: through study completion, an average of 2 hours
Neuropsychiatric Inventory (NPI) subscales Impact on the workload of the caregiver.
Time frame: through study completion, an average of 2 hours
mini-mental state examination (MMSE) score
Time frame: through study completion, an average of 2 hours
Concentration of cortisol from saliva samples
Time frame: Once, at Day 1, baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Puissieux, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Balance Board in people with Alzheimer Disease, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of consistency (oppositive of variability) (time frame: Baseline, before SMS task). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.