- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702594
Music Therapy and Psycho-behavioral Disorders in the Elderly Population (DEMUse)
Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne FRELY, MD
- Phone Number: 04.72.16.71.41
- Email: anne.frely@chu-lyon.fr
Study Contact Backup
- Name: Blandine DE-LA-GASTINE, MD
- Phone Number: 04.72.16.71.14
- Email: blandine.de-la-gastine@chu-lyon.fr
Study Locations
-
-
-
Lyon, France, 69005
- Recruiting
- Hopital Pierre Garraud
-
Contact:
- Anne FRELY,, PH
- Phone Number: 04.72.16.71.41
- Email: anne.frely@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unpaired deafness
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: UHR and SRH
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evolution of the NeuroPsychiatric Inventory (NPI) scale
Time Frame: Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0489
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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