Clinical trial NCT06688968: Neuropsychological Profiles and Musical Engagement in Parkinson's and Alzheimer's Disease
Official title: Observational Pilot Study of Neuropsychological Profiles and Musical Engagement in Parkinson's and Alzheimer's Disease. What Are the Effects of Mnestic or Hedonic Impairment on Emotion, Reminiscence and Musical Enjoyment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Parkinsons Disease with Dementia
Non Pharmacological Intervention
Keywords: Non Pharmacological intervention
Alzheimer Disease, Early Onset
Parkinsons Disease with Dementia
Music Therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Laboratoire EPSYLON
First posted: 2024-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter observational pilot study
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this Multicenter observational pilot study is to Compare the specifics of musical engagement (behaviors related to music in everyday life) in subjects aged over 60 with Alzheimer s disease, Parkinson s disease and control subjects.

The main questions it aims to answer are:

1. The description of different profiles of musical engagement in early-stage AD, in PD and in healthy elderly subjects.
2. The extent of executive, mnestic and hedonic dysfunctions will impact differently on emotional engagement, autobiographical evocation and sensitivity to musical reward, and will therefore enable distinct profiles to be drawn up.

Participants will have an intervention consisting of an interview with a neuropsychologist lasting approximately 2 hours, including :

* A semi-structured interview to check the participants eligibility and gather demographic data.
* Neuropsychological tests and questionnaires will then be administered.
* A relative of the study participant will help complete questionnaires.

Detailed description: Music therapy appears to be highly relevant as a Non-Medication Intervention in Alzheimer s (AD) and Parkinson s disease (PD). It is said to reduce depressive symptoms following music therapy sessions in dementia . With regard to Parkinson s disease, music therapy brings benefits in terms of motor skills, communication, breathing and emotional aspects. Reviews point to the need to differentiate beneficial effects according to different pathologies.

To date, no study has investigated the evolution of sensitivity to musical reward in AD. Furthermore, no study has discriminated the evolution of musical engagement in several neurodegenerative pathologies.

Eligibility criteria: Inclusion Criteria:

General inclusion criteria:

* 60 years and older
* French-speaking and volunteering for the study
* Living at home with a relative

Alzheimer's disease inclusion criteria:

* Biological diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria (McKhann et al., 1984)
* MMSE greater than or equal to 20

Inclusion criteria Parkinson's disease :

* Diagnosis of Idiopathic Parkinson's disease
* MMSE greater than or equal to 20

Exclusion Criteria:

* No known neurological pathologies (epilepsy and other non-degenerative CNS diseases) or psychiatric disorders (chronic psychosis and psychotic episodes)
* Autistic disorders
* History of stroke or head trauma
* Unstable medical condition (cancer)
* Subject unable to read and/or write
* Hearing impairment without hearing aids
* Refusal of consent after information
* Persons unable to give consent, research carried out in emergency situations, etc.)
* Non-affiliation with a social security scheme
* Person deprived of liberty (by judicial or administrative decision, or forced hospitalization)
* Person under legal protection (guardianship, curatorship, legal protection)
* Person participating in another research project with an exclusion period still in progress

Primary outcomes:
measure: Comparison of the specificities of musical engagement (i.e., music-related behaviors in daily life) in Alzheimer's disease, Parkinson's disease, and among a population of healthy old adults.
timeFrame: Baseline
Secondary outcomes:
measure: The comparison of self- and hetero-questionnaires will be carried out within each group for each MUseQ24 dimension
timeFrame: Baseline
measure: Comparison of global cognition between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Executive Function between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Episodic Memory Function between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Semantic Memory Function between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Musical Cognition between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Semantic Musical Memory between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Sensitivity to musical reward between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Self-assessed musical engagement between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Memory recall during music listening reward between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of emotional experience during music listening during music listening reward between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Hedonic function reward between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Affective blunting between Alzheimer's, Parkinson's and healthy elderly groups
timeFrame: Baseline
measure: Comparison of Depression symptoms
timeFrame: Baseline
measure: Correlation between the Barcelona Reward Music Questionnaire (BMRQ) and the Wisconsin Card Sorting Test (WCST) for each group
timeFrame: Baseline
measure: Correlation between the Barcelona Reward Music Questionnaire (BMRQ) and the 16-item free recall/indexed recall test (RL/RI- 16) for each group
timeFrame: Baseline
measure: Correlation between Barcelona Reward Music Questionnaire (BMRQ) and Lille's Apathy Rating Scale (LARS) subscale for each group
timeFrame: Baseline
measure: Correlation between the Barcelona Reward Music Questionnaire (BMRQ) and the Snaith-Hamilton Pleasure Scale (SHAPS) for each group
timeFrame: Baseline
measure: Correlation between the Emotion Subscale of the MusEQ 24 hetero-reported version and the Wisconsin Card Sorting Test (WCST) for each group
timeFrame: Baseline
measure: Correlation between the Emotion subscale of the MusEQ 24 hetero-reported version and the 16-item free recall/indexed recall test (RL/RI- 16) for each group.
timeFrame: Baseline
measure: Correlation between the Emotion subscale of the MusEQ 24 hetero-reported version and the Lille's Apathy Rating Scale (LARS) subscale for each group
timeFrame: Baseline
measure: Correlation between the Emotion Subscale of the MusEQ 24 hetero-reported version and the Snaith-Hamilton Pleasure Scale (SHAPS) for each group
timeFrame: Baseline
measure: Correlation between Item 22 of the MusEQ-24 hetero-reported version and Wisconsin Card Sorting Test (WCST) for each group
timeFrame: Baseline
measure: Correlation between item 22 of the MusEQ-24 hetero-reported version with 16-item free recall/indexed recall test (RL/RI- 16) for each group
timeFrame: Baseline
measure: Correlation between Item 22 of the MusEQ-24 hetero-reported version and the Lille's Apathy Rating Scale (LARS) subscale for each group
timeFrame: Baseline
measure: Correlation between Item 22 of the MusEQ-24 hetero-reported version and the Snaith-Hamilton Pleasure Scale (SHAPS) for each group
timeFrame: Baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier Seniors' Association
state: Hérault
city: Montpellier
country: France
facility: CHU de Montpellier - CEPMo
state: Hérault
city: Montpellier
country: France
facility: CHU de Montpellier - CMRR
state: Hérault
Study officials:
affiliation: University Hospital, Montpellier
name: KARIM BENNYS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bian X, Wang Y, Zhao X, Zhang Z, Ding C. Does music therapy affect the global cognitive function of patients with dementia? A meta-analysis. NeuroRehabilitation. 2021;48(4):553-562. doi: 10.3233/NRE-210018.
citation: Zhang Y, Cai J, An L, Hui F, Ren T, Ma H, Zhao Q. Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev. 2017 May;35:1-11. doi: 10.1016/j.arr.2016.12.003. Epub 2016 Dec 23.
citation: van der Steen JT, van Soest-Poortvliet MC, van der Wouden JC, Bruinsma MS, Scholten RJ, Vink AC. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2017 May 2;5(5):CD003477. doi: 10.1002/14651858.CD003477.pub3.
citation: Platel H, Eustache ML, Coppalle R, Viard A, Eustache F, Groussard M, Desgranges B. Boosting Autobiographical Memory and the Sense of Identity of Alzheimer Patients Through Repeated Reminiscence Workshops? Front Psychol. 2021 Feb 15;12:636028. doi: 10.3389/fpsyg.2021.636028. eCollection 2021.
citation: Morris IB, Vasudevan E, Schedel M, Weymouth D, Loomis J, Pinkhasov T, Muratori LM. Music to One's Ears: Familiarity and Music Engagement in People With Parkinson's Disease. Front Neurosci. 2019 Jun 25;13:661. doi: 10.3389/fnins.2019.00661. eCollection 2019.
citation: Machado Sotomayor MJ, Arufe-Giraldez V, Ruiz-Rico G, Navarro-Paton R. Music Therapy and Parkinson's Disease: A Systematic Review from 2015-2020. Int J Environ Res Public Health. 2021 Nov 4;18(21):11618. doi: 10.3390/ijerph182111618.
citation: Loas G, Duru C, Godefroy O, Krystkowiak P. Hedonic deficits in Parkinson's disease: is consummatory anhedonia specific? Front Neurol. 2014 Mar 10;5:24. doi: 10.3389/fneur.2014.00024. eCollection 2014.
citation: Groussard M, Chan TG, Coppalle R, Platel H. Preservation of Musical Memory Throughout the Progression of Alzheimer's Disease? Toward a Reconciliation of Theoretical, Clinical, and Neuroimaging Evidence. J Alzheimers Dis. 2019;68(3):857-883. doi: 10.3233/JAD-180474.
citation: Belfi AM, Moreno GL, Gugliano M, Neill C. Musical reward across the lifespan. Aging Ment Health. 2022 May;26(5):932-939. doi: 10.1080/13607863.2021.1871881. Epub 2021 Jan 14.