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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03543-50 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| France Alzheimer | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with neurodegenerative disease | Active Comparator | Patients with neurodegenerative disease (AD or related disease) |
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| People with no neuropathological disease | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a virtual experimenter; |
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Inclusion Criteria:
Cases : Patients with neurodegenerative disease (AD or related disease)
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| François Puissieux, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital les Bateliers, CHU | Lille | France |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003142 | Communication |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Concentration of cortisol from saliva samples | measure the saliva cortisol before and after the synchronization task | Once, at Day 1, baseline |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |