search
Back to results

MusiCare: Music Therapy & Innovative Technology (MusiCare)

Primary Purpose

Healthy Aging, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Middlesex University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Aging focused on measuring music therapy, aging, cognitive function, robotics

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged ≥65yrs
  • No significant hearing impairment that would negatively interfere with the music-based interventions
  • Fluent in English
  • Healthy group - MMSE ≥ 24
  • Cognitive impairment: mild MMSE= 18-23, moderate MMSE= 10-17

Exclusion Criteria:

  • Presence of severe motor deficits that would not allow individuals to participate in the intervention
  • Having taken part in a cognitive training programme or Music Therapy programme within the last 6 months.

Sites / Locations

  • MHA Methodist HomesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

One2One

Small-group

Control

Arm Description

1) Weekly individual (one2one) Music Therapy intervention lasting 5 months (n=20 sessions)

2) Weekly small group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)

Standard weekly music social listening in large group available in all care-homes. Lasting 5 months (n=20 sessions)

Outcomes

Primary Outcome Measures

General cognitive functions change from baseline/post (i.e., time 0/+5 months)
Mini-Mental State Examination (MMSE, Folstein et al., 1975): A world standardized tool for screening general cognitive function which allows the client to be placed on a cognitive functioning scale. This test is usually used to follow the course of a disease or for monitoring the response to a specific treatment, as in this case.
Music related cognitive function change from baseline/post (i.e., time 0/+5 months)
Music Cognitive Test (MCT, Mangiacotti, 2019; - et al., 2019b) A music-based cognitive test to measure cognitive functions typically stimulated by rehabilitative music interventions.
Attentional functions change from baseline/post (i.e., time 0/+5 months)
TMT-A (Reitan & Wolfoson, 1985) The test assesses selective attention and psychomotor speed.
Executive and spatial-cognitive abilities change from baseline/post (i.e., time 0/+5 months)
Tangled Figure Test (Arcara et al., 2011) The test wants to evaluate participant's ability to perform figure-background discrimination and inhibition on the answers already provided as well as to recognize the contours of the figures. Mainly it is a test of visual recognition, but it requires the ability to reorganize a complex visual pattern in order to identify an increasing number of figures. Provides information on spatial-cognitive abilities, and executive and naming difficulties.

Secondary Outcome Measures

Quality of Life change from baseline/post (i.e., time 0/+5 months)
• Quality of Life in Alzheimer's Disease (Logsdon et al., 1999); The test measure quality of life in dementia. Rating is got from both the participant and the caregiver.
Mood Index change from baseline/post (i.e., time 0/+5 months)
• Cornell Scale for Depression in Dementia (CSDD, Alexopoulos, Abrams, Young, & Shamoian, 1988); This test is specifically designed to screen depressive symptoms in older adults with dementia and cognitive impairment. It is an interviewer-administered scale relying on information from caregivers and clinician's observations.
Neuro-psychiatric symptoms change from baseline/post (i.e., time 0/+5 months)
• Neuro-Psychiatric Inventory (NPI, Cummings, 1994) A tool that provides information on the presence of psychopathology in people with brain disorders. The NPI was developed for people with Alzheimer's disease and other dementias, but it may be useful in the assessment of behavioural changes in other conditions.
Cognitive reserve
· Cognitive Reserve Index Questionnaire (CRI-Q, Nucci, Mapelli, Mondini, 2012). A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve". This test is useful in the research setting to balance study groups, as occur this project.

Full Information

First Posted
March 29, 2021
Last Updated
August 23, 2022
Sponsor
Middlesex University
Collaborators
The Dunhill Medical Trust, University of Padova, Vrije Universiteit Brussel, University of Dublin, Trinity College
search

1. Study Identification

Unique Protocol Identification Number
NCT04851028
Brief Title
MusiCare: Music Therapy & Innovative Technology
Acronym
MusiCare
Official Title
MusiCare: Protecting Cognitive Functions and Wellbeing Using Music Therapy & Innovative Technology With an Aging Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Middlesex University
Collaborators
The Dunhill Medical Trust, University of Padova, Vrije Universiteit Brussel, University of Dublin, Trinity College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The number of older people living with cognitive impairment or dementia has increased the need for simple, inexpensive interventions to improve the quality of life for such individuals and their families. Policy-makers sensitive to issues associated with mental health challenges in aging have embraced social prescribing, and a wealth of research has flourished to study non-pharmacological forms of preventative intervention. Can music-therapy(MT) be one of them? Different studies demonstrated that music stimulates a range of cognitive and social functions. However, scientific studies assessing the value of MT for those who need support in later life are limited, and rigorous research is required to generate robust scientific evidence. The focus of this study is on developing novel forms of intervention for older adults who are healthy or experiencing mild-to-moderate cognitive decline, aiming at [i]understanding whether MT could be used in preventive programs to support cognitive functions, [ii]identifying the best match between types of MT and levels of cognitive decline. Moreover, recent developments of Robotic-Assistance-Technologies offer opportunities to explore how such technologies may be used to contribute to older adults wellbeing when integrated within care routines to facilitate MT delivery. Spanning across three-studies, the investigators will examine psychosocial benefits of 5-month MT interventions (one2one vs small-group MT) in healthy older adults and impaired older adults in care homes, compared to standard care. This latter group will receive MT afterwards. Further, researchers will investigate whether Robotic-Assistance-Technologies may enrich MT interventions and have additional benefits for the participants and translatability for community-based services. In order to measure these effects, psychological (cognitive functions, wellbeing, quality of life) and physiological (hormonal, cardiovascular & brain activity) measures will be compared before/after the intervention. The study will elucidate relationships between different types of MT and benefits to participants wellbeing, cognitive functions & social engagement, as well as the impact of robotic assistive technologies in public health services and social care.
Detailed Description
The following objectives are addressed: [Oi] Identifying a consistent set of convergent measures for the reliable assessment of cognition/well-being in MT studies integrating psychological measures with biomarkers; [Oii] Implementing robust MT protocols benefitting cognitive functions/well-being in ageing individuals with varying cognitive ability; [Oiii] Comparing the outcomes of one2one/small-group MT intervention in function of participants' cognitive abilities (ranging from healthy ageing to moderate impairment); [Oiv] Devising, implementing and testing a robotic platform associated with MT to facilitate therapists/caregivers' work through novel forms of interaction with ageing individuals, and potential translatability to communities. Our research questions/hypotheses are: [H1] Will MT benefits healthy, mildly and moderately impaired 65+ in outcome measures? MT > standard care. [H2] Which MT treatment (one2one/small group) is more effective in function of older adults' cognitive level? Best outcomes predicted as follows: healthy 65+ with small-group MT; for mildly impaired 65+, one2one = small-group MT; moderately impaired 65+ with one2one MT. [H3] Will improvements in cognitive functions derived from MT be associated with psychophysiological biomarkers? Convergent measures will be identified linking cognitive, behavioural and physiological improvement. [H4] What are the benefits of MT for caregivers? A reduction in participant psychiatric and depressive symptoms will correspond to caregivers' workload and stress perception decrease. [H5] Are there benefits from enriching MT with robotic technology? Specifically, the investigators hypothesize that a) the robot will have the capability of delivering interactive music training sessions, with the support of caregivers not specialised in MT and b) the continuous monitoring provided by the robotic platform will enhance the information available to therapists/caregivers without significantly burdening them. MusiCare aims are: [Ai] Provide care-homes, communities and policy-makers with clear guidelines concerning the utility, suitability and cost-effectiveness of Music Therapy (MT) interventions (one2one vs small-group) as a prevention/rehabilitation method suitable for social prescribing and support for positive ageing. [Aii] Provide music therapists with robust protocols, new tests specifically designed to work through musical tasks (Music Cognitive Test). [Aiii] Provide scholars/practitioners with a range of objective measures to select from, depending on their needs, in order to evaluate MT interventions in ageing. [Aiv] Explore how the assistive robotic technologies can enrich MT in care-home settings by empowering care-home staff with a new active role in assisting rehabilitative activities as well as facilitating inter-generational communication between families and ageing relatives. [Av] Increase public awareness about healthy ageing, and arts & wellbeing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging, Cognitive Impairment
Keywords
music therapy, aging, cognitive function, robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One2One
Arm Type
Experimental
Arm Description
1) Weekly individual (one2one) Music Therapy intervention lasting 5 months (n=20 sessions)
Arm Title
Small-group
Arm Type
Experimental
Arm Description
2) Weekly small group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard weekly music social listening in large group available in all care-homes. Lasting 5 months (n=20 sessions)
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
Music therapy is a non-pharmacological intervention, in which music and its elements are used professionally as an intervention in medical, educational, and everyday environments with individuals, groups, families, or communities who seek to optimize their quality of life and improve their physical, social, communicative, emotional, intellectual, and spiritual health and wellbeing. This therapy has shown to provide significant benefits for individuals with cognitive decline living in care homes, enhancing social-cognitive functions and reducing behavioural symptoms (Brotons & Koger, 2000; Hsu et al., 2015; Zhang et al., 2017).
Primary Outcome Measure Information:
Title
General cognitive functions change from baseline/post (i.e., time 0/+5 months)
Description
Mini-Mental State Examination (MMSE, Folstein et al., 1975): A world standardized tool for screening general cognitive function which allows the client to be placed on a cognitive functioning scale. This test is usually used to follow the course of a disease or for monitoring the response to a specific treatment, as in this case.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Music related cognitive function change from baseline/post (i.e., time 0/+5 months)
Description
Music Cognitive Test (MCT, Mangiacotti, 2019; - et al., 2019b) A music-based cognitive test to measure cognitive functions typically stimulated by rehabilitative music interventions.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Attentional functions change from baseline/post (i.e., time 0/+5 months)
Description
TMT-A (Reitan & Wolfoson, 1985) The test assesses selective attention and psychomotor speed.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Executive and spatial-cognitive abilities change from baseline/post (i.e., time 0/+5 months)
Description
Tangled Figure Test (Arcara et al., 2011) The test wants to evaluate participant's ability to perform figure-background discrimination and inhibition on the answers already provided as well as to recognize the contours of the figures. Mainly it is a test of visual recognition, but it requires the ability to reorganize a complex visual pattern in order to identify an increasing number of figures. Provides information on spatial-cognitive abilities, and executive and naming difficulties.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Secondary Outcome Measure Information:
Title
Quality of Life change from baseline/post (i.e., time 0/+5 months)
Description
• Quality of Life in Alzheimer's Disease (Logsdon et al., 1999); The test measure quality of life in dementia. Rating is got from both the participant and the caregiver.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Mood Index change from baseline/post (i.e., time 0/+5 months)
Description
• Cornell Scale for Depression in Dementia (CSDD, Alexopoulos, Abrams, Young, & Shamoian, 1988); This test is specifically designed to screen depressive symptoms in older adults with dementia and cognitive impairment. It is an interviewer-administered scale relying on information from caregivers and clinician's observations.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Neuro-psychiatric symptoms change from baseline/post (i.e., time 0/+5 months)
Description
• Neuro-Psychiatric Inventory (NPI, Cummings, 1994) A tool that provides information on the presence of psychopathology in people with brain disorders. The NPI was developed for people with Alzheimer's disease and other dementias, but it may be useful in the assessment of behavioural changes in other conditions.
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Cognitive reserve
Description
· Cognitive Reserve Index Questionnaire (CRI-Q, Nucci, Mapelli, Mondini, 2012). A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve". This test is useful in the research setting to balance study groups, as occur this project.
Time Frame
Baseline (i.e., time 0)
Other Pre-specified Outcome Measures:
Title
Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+5 months)
Description
Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant: Before lunchtime (11.00am to 12.30am); Before dinner (4pm to 5pm); Evening (from 7pm to 8pm).
Time Frame
Baseline vs. post- intervention period (time 0/+5-months)
Title
Salivary Hormones index (cortisol/DHEA ratio) change from baseline/mid-intervention(i.e., time 0/+10 weeks)
Description
Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant: Before lunchtime (11.00am to 12.30am); Before dinner (4pm to 5pm); Evening (from 7pm to 8pm).
Time Frame
Baseline vs. mid-intervention period (time 0/+10 weeks)
Title
Salivary Hormones index (cortisol/DHEA ratio) change from mid-/post-intervention (i.e., 10weeks/5 months)
Description
Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant: Before lunchtime (11.00am to 12.30am); Before dinner (4pm to 5pm); Evening (from 7pm to 8pm).
Time Frame
Mid-intervention period (10 weeks) vs. post-intervention (5 months)
Title
RSA change from baseline/post (i.e., time 0/+5 months)
Description
• Respiratory sinus arrhythmia (RSA): 5 min resting state
Time Frame
Baseline and post- intervention period (time 0/+5-months)
Title
EEG change from baseline/post (i.e., time 0/+5 months)
Description
• Neural tracking of natural speech and musical sound: EEG measures of cortical activity (Di Liberto et al., 2015, 2020) - 8 electrodes, 15 minutes.
Time Frame
Baseline and post- intervention period (time 0/+5-months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged ≥65yrs No significant hearing impairment that would negatively interfere with the music-based interventions Fluent in English Healthy group - MMSE ≥ 24 Cognitive impairment: mild MMSE= 18-23, moderate MMSE= 10-17 Exclusion Criteria: Presence of severe motor deficits that would not allow individuals to participate in the intervention Having taken part in a cognitive training programme or Music Therapy programme within the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabia Franco, PhD
Phone
020 8411 5471
Email
f.franco@mdx.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Mangiacotti
Phone
07551855232
Email
a.mangiacotti@mdx.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabia Franco, PhD
Organizational Affiliation
Middlesex University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MHA Methodist Homes
City
Derby
ZIP/Postal Code
DE1 2EQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Hung Hsu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
An anonymised dataset will be created with all the cognitive and physiological data collected from participants that will give consent to share their anonymised data.
IPD Sharing Time Frame
to be defined
IPD Sharing Access Criteria
to be defined
Citations:
PubMed Identifier
10990596
Citation
Brotons M, Koger SM. The impact of music therapy on language functioning in dementia. J Music Ther. 2000 Fall;37(3):183-95. doi: 10.1093/jmt/37.3.183.
Results Reference
background
PubMed Identifier
26183582
Citation
Hsu MH, Flowerdew R, Parker M, Fachner J, Odell-Miller H. Individual music therapy for managing neuropsychiatric symptoms for people with dementia and their carers: a cluster randomised controlled feasibility study. BMC Geriatr. 2015 Jul 18;15:84. doi: 10.1186/s12877-015-0082-4.
Results Reference
background
PubMed Identifier
28025173
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.
Results Reference
background
PubMed Identifier
6860082
Citation
Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.
Results Reference
background
PubMed Identifier
21691143
Citation
Nucci M, Mapelli D, Mondini S. Cognitive Reserve Index questionnaire (CRIq): a new instrument for measuring cognitive reserve. Aging Clin Exp Res. 2012 Jun;24(3):218-26. doi: 10.3275/7800. Epub 2011 Jun 20.
Results Reference
background
PubMed Identifier
3337862
Citation
Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
Results Reference
background
PubMed Identifier
7991117
Citation
Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
Results Reference
background
PubMed Identifier
26412129
Citation
Di Liberto GM, O'Sullivan JA, Lalor EC. Low-Frequency Cortical Entrainment to Speech Reflects Phoneme-Level Processing. Curr Biol. 2015 Oct 5;25(19):2457-65. doi: 10.1016/j.cub.2015.08.030. Epub 2015 Sep 24.
Results Reference
background
PubMed Identifier
32122465
Citation
Di Liberto GM, Pelofi C, Bianco R, Patel P, Mehta AD, Herrero JL, de Cheveigne A, Shamma S, Mesgarani N. Cortical encoding of melodic expectations in human temporal cortex. Elife. 2020 Mar 3;9:e51784. doi: 10.7554/eLife.51784.
Results Reference
background
Citation
Biggio, G. and Mostallino, M.C., 2013. Stress, cortisol, neuronal plasticity, and depressive disorder. Journal of Psychopathology, 19, pp.77-83.
Results Reference
background
Citation
Logsdon, R.G., Gibbons, L.E., McCurry, S.M. and Teri, L., 1999. Quality of life in Alzheimer's disease: patient and caregiver reports. Journal of Mental health and Aging, 5, pp.21-32.
Results Reference
background
Citation
Arcara, G., Bisiacchi, P. S., Mapelli, D., Mondini, S., & Vestri, A. 2011. Esame Neuropsicologico Breve (ENB-2): una batteria di test per lo screening neuropsicologico, Raffaello Cortina Editore, Milano.
Results Reference
background
Citation
Reitan, R. M., & Wolfson, D. (2009). The Halstead-Reitan neuropsychological test battery for adults-theoretical, methodological, and validational bases. Neuropsychological assessment of neuropsychiatric and neuromedical disorders, 1, 3-24.
Results Reference
background
Citation
Mangiacotti, A., Cipriani, G., Ward, E., Franco, F. and Biasutti, M., 2019b. The Music Cognitive Test: A new music-based cognitive test. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 15(7), pp.446-P447.
Results Reference
background
Citation
Mangiacotti, A., Hsu, M.H., Barone, C., Di Liberto, G., Van Puyvelde, M., Biasutti, M. and Franco, F., 2019a. Effects of music therapy in elderly care: cognition, biomarkers, mood and social behaviour. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 15(7), p.1144.
Results Reference
background
Citation
Mangiacotti, A., PhD Thesis, "The Music Cognitive Test validation, training and applicability of a music-based cognitive tool for music therapists - an interdisciplinary study" University of Padua (submitted October 2019 - Viva passed 9th March 2020).
Results Reference
background

Learn more about this trial

MusiCare: Music Therapy & Innovative Technology

We'll reach out to this number within 24 hrs