Clinical trial NCT04546451: Countervail Cognitive and Cerebral Decline in Mild Cognitive Impairment Patients Using Non-medical Interventions
Official title: Musical and Psychomotor Interventions for Cognitive, Sensorimotor, and Cerebral Decline in Patients With Mild Cognitive Impairment (COPE): a Study Protocol for a Multicentric Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Randomized Controlled Trial
Non-medical interventions
Cognitive performance
Sensorimotor performance
Experience induced brain plasticity
Music Practice
Psychomotor training
Passive Control Group
Multivariate data-driven analyses
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: University of Geneva, Switzerland
name: University of Lausanne Hospitals
First posted: 2020-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 experimental conditions (Music practice vs. Psychomotor training) and 1 passive control condition
Primary purpose: TREATMENT

Brief summary: Cognitive decline represents a major threat among the deleterious effects of population aging. The investigators propose to conduct an RCT (randomized controlled trial) on the subpopulation of MCI patients, and examine whether intensive musical or psychomotor group interventions can improve their cognitive and sensorimotor functioning, as well as induce brain plasticity, compared to a passive healthy control group, matched for age, gender and education level. The 2 training regimens will take place twice a week over 6 months and will be provided by professionals in each field.

Detailed description: Background Regular cognitive training can boost or maintain cognitive and brain functions known to decline with age. Most studies administered such cognitive training on a computer and in a lab setting. However, everyday life activities, like musical practice or physical exercise that are complex and variable, could be more successful at inducing transfer effects to different cognitive domains and maintaining motivation. "Body-mind exercises", like Tai Chi or psychomotor exercise, may also positively affect cognitive functioning in the elderly. We will investigate the influence of active music practice and psychomotor training over 6 months in Mild Cognitive Impairment patients from university hospital memory clinics on cognitive and sensorimotor performance and brain plasticity.

Methods We aim to conduct a randomized controlled (RCT) multicenter intervention study on 32 Mild Cognitive Impairment (MCI) patients (60-80 years), divided over 2 experimental groups: 1) Music practice; 2) Psychomotor treatment. Controls will consist of a passive test-retest group of 16 age, gender and education level matched healthy volunteers.

The training regimens take place twice a week for 45 minutes over 6 months in small groups, provided by professionals, and patients should exercise daily at home. Data collection takes place at baseline (before the interventions), 3, and 6 months after training onset, on cognitive and sensorimotor capacities, subjective well-being, daily living activities, and via functional and structural neuroimaging. Considering the current constraints of the ongoing COVID-19 (COronaVIrus Disease of 2019) pandemic, recruitment and data collection takes place in 2 waves.

Discussion We will investigate whether musical practice or psychomotor exercise in small groups can improve cognitive, sensorimotor and brain functioning in MCI patients, and therefore provoke benefits for their daily life functioning and well-being.

Eligibility criteria: Inclusion criteria

1. MCI diagnosis by experts at the memory clinics
2. MMSE score (Mini-Mental State Examination) \> 22 or MoCA (Montreal Cognitive Assessment) \> 18
3. Hospital Anxiety and Depression Scale (HADS) \< 14 (\< 7/21 for anxiety and \< 7/21 for depression)
4. Age between 60 and 80 years
5. Right-handedness
6. Fluent in French
7. Able to give informed consent as documented by signature

Exclusion Criteria:

1. Serious motor deficits
2. Impaired/not-corrected hearing
3. Serious physical and mental comorbidities
4. Participation in physical or cognitive training over the last 12 months
5. Maximum 5 years of official music education over the lifespan outside the school curriculum or during the last 3 years
6. Intensive physical activity over the last 12 months (sports or body-mind exercises)
7. Left-handed or ambidextrous
8. MRI incompatibility (claustrophobia, cardiac stimulator, implants...)

Nota bene: for brain organizational reasons exclusively right-handed participants will be included. Right-handed persons represent more than 90% of the population (Isaacs, Barr, Nelson, \& Devinsky, 2006., doi:10.1212/01.wnl.0000219623.28769.74.)

Primary outcomes:
measure: Cognitive Telephone Screening Instrument (COGTEL)
timeFrame: 6 months
Secondary outcomes:
measure: Individual subtests of the COGTEL (Cognitive Telephone Screening Instrument)
timeFrame: 6 months
measure: D2-R test
timeFrame: 6 months
measure: Trail making test
timeFrame: 6 months
measure: Go/No-Go
timeFrame: 6 months
measure: International Matrix Test (Oldenburg)
timeFrame: 6 months
measure: fMRI visual working memory task
timeFrame: 6 months
measure: Sensorimotor function
timeFrame: 6 months
measure: Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire (A-IADL-Q(SV))
timeFrame: 6 months
measure: World Health Organization Quality of Life Instruments - short Version WHOQOL-BREF (abbreviated World Health Organization Quality of Life; WHO 1996)
timeFrame: 6 months
measure: Emotional regulation questionnaire (ERQ)
timeFrame: 6 months
measure: Magnetization Prepared 2 Rapid Gradient Echo (MP2RAGE)
timeFrame: 6 months
measure: Functional MRI (fMRI)
timeFrame: 6 months
measure: Resting state functional MRI (RS-fMRI)
timeFrame: 6 months
measure: Diffusion Tensor Imaging (DTI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV: Centre Leenaards Memory Center
state: Vaud
city: Geneva
country: Switzerland
facility: School of Health Sciences Geneva HES-SO
Study officials:
affiliation: University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland
name: Clara E. James, PhD
role: PRINCIPAL_INVESTIGATOR
References: