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临床试验/NCT04146688
NCT04146688已完成不适用

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

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
2
主要终点
measure of consistency (oppositive of variability)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Patients with neurodegenerative disease

Active Comparator

Patients with neurodegenerative disease (AD or related disease)

干预措施: Music Balance Board (Other)

People with no neuropathological disease

Active Comparator

干预措施: Music Balance Board (Other)

结局指标

主要结局

measure of consistency (oppositive of variability)

时间窗: 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.

时间窗: 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

次要结局

  • Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a real experimenter(Baseline, before SMS task)
  • Measurement of the Music Balance Board (cf. primary outcome) during music in the presence of a virtual experimenter;(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(after SMS task, an average after 45 min)
  • STAI Anxiety Scale Score(through study completion, an average of 2 hours)
  • Scale of Instrumental Activities of Daily Living(through study completion, an average of 2 hours)
  • mini-mental state examination (MMSE) score(through study completion, an average of 2 hours)
  • Measurement of the Music Balance Board (cf. primary outcome) during metronome in the presence of a virtual experimenter.(after SMS task, an average after 45 min)
  • Decoding of non-verbal behaviors during the synchronization task(after SMS task, an average after 45 min)
  • Intensity of body movements (quantity of motion)(after SMS task, an average after 45 min)
  • Decoding of the frequency (number of behaviors / duration of the condition) of the facial expressions(through study completion, an average of 2 hours)
  • Scale of Assessment of Daily Activities(through study completion, an average of 2 hours)
  • Concentration of cortisol from saliva samples(Once, at Day 1, baseline)
  • Neuropsychiatric Inventory (NPI) subscales Impact on the workload of the caregiver.(through study completion, an average of 2 hours)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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