NCT04146688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started May 2018

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

January 9, 2019

Last Update Submit

November 19, 2020

Conditions

Keywords

MusicCommunicationEmotionBehaviorNeurodegeneration disease

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (13)

  • 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

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Patients with neurodegenerative disease

ACTIVE COMPARATOR

Patients with neurodegenerative disease (AD or related disease)

Other: Music Balance Board

People with no neuropathological disease

ACTIVE COMPARATOR
Other: Music Balance Board

Interventions

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.

Patients with neurodegenerative diseasePeople with no neuropathological disease

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital les Bateliers, CHU

Lille, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseCommunicationBehavior

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • François Puissieux, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Puissieux, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

October 31, 2019

Study Start

May 17, 2018

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations