Countervail Cognitive and Cerebral Decline in Mild Cognitive Impairment Patients Using Non-medical Interventions (COPE)

School of Health Sciences Geneva

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Psychomotor therapy; Behavioral: Music practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04546451

99861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Music practice

Experimental group

Description:

Patients will receive Music Practice interventions of 45 minutes twice a week over 6 months, provided by a professional musician

Treatment:

Behavioral: Music practice

Psychomotor therapy

Experimental group

Description:

Patients will receive Psychomotor interventions of 45 minutes twice a week over 6 months, provided by a professional psychomotor therapist

Treatment:

Behavioral: Psychomotor therapy

Passive control group

No Intervention group

Description:

Healthy passive controls will pass all measurements without any intervention. The control group participants must adhere to the same inclusion and exclusion criteria as the experimental groups, except for an MCI diagnosis. Control participants will be matched to the experimental groups for age, gender and education level.