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

NCT ID: NCT04546451

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-05-27

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music practice

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

Group Type: EXPERIMENTAL

Music practice

Intervention Type: BEHAVIORAL

Patients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles.

Psychomotor therapy

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

Group Type: EXPERIMENTAL

Psychomotor therapy

Intervention Type: BEHAVIORAL

Patients will be trained in body awareness and a wide range of of movement activities.

Passive control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music practice

Patients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles.

Intervention Type: BEHAVIORAL

Psychomotor therapy

Patients will be trained in body awareness and a wide range of of movement activities.

Intervention Type: BEHAVIORAL

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.)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

School of Health Sciences Geneva

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clara E. James, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland

Locations

CHUV: Centre Leenaards Memory Center

Lausanne, Canton of Vaud, Switzerland

School of Health Sciences Geneva HES-SO

Geneva, , Switzerland

Countries

Switzerland

References

James CE, Stucker C, Junker-Tschopp C, Fernandes AM, Revol A, Mili ID, Kliegel M, Frisoni GB, Brioschi Guevara A, Marie D. 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. BMC Geriatr. 2023 Feb 6;23(1):76. doi: 10.1186/s12877-022-03678-0.

Reference Type: DERIVED

PMID: 36747142 (View on PubMed)

Other Identifiers

99861

Identifier Type: -

Identifier Source: org_study_id