NCT04702594

Brief Summary

Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions. However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.

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
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

January 7, 2021

Last Update Submit

July 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evolution of the NeuroPsychiatric Inventory (NPI) scale

    The improvement in psycho-behavioral symptoms will be assessed by the NPI score provided by the MUSIC CARE application carried out by a caregiver.

    Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)

Study Arms (1)

UHR and SRH

EXPERIMENTAL

All patients over the age of 60 present in the UHR and hospitalized in SRH with behavioral disorders in the context of a neurocognitive disorder

Behavioral: Music therapy session via tools validated by MUSIC CARE

Interventions

Use of the MUSICARE tool, a digital space allowing access to different validated methods of music therapy. Music listening times are offered to patients with cognitive impairment with psycho-behavioral symptoms. The sessions are individual or group performed by a psychomotor therapist in UHR and volunteer caregivers trained in SRH. The sessions last on average 20-30min.

UHR and SRH

Eligibility Criteria

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

You may qualify if:

  • Patients over the age of 60 present in the reinforced hospital unit during the study period
  • Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder

You may not qualify if:

  • Unpaired deafness
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pierre Garraud

Lyon, 69005, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

January 18, 2021

Primary Completion

August 18, 2021

Study Completion

August 18, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations