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

NCT04546451 | Completed DMC

• 1 other identifier: 99861
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Cognitive Telephone Screening Instrument (COGTEL)

  This test can be applied by telephone or face-to-face (in this study we will apply the face-to-face method). The outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test directly after the 6 months interventions as compared to directly before the interventions. The COGTEL test provides a main weighted score of core cognitive function, it comprises 6 subtests covering prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency and inductive reasoning. COGTEL main weighted score: COGTEL Total score = 7.2 x Prospective Memory score + 1.0 x Verbal Short-Term Memory score + 0.9 x Verbal Long-Term Memory score + 0.8 x Working Memory score + 0.2 x Verbal Fluency score + 1.7 x Inductive Reasoning score (Kliegel, Martin, \& Jager, 2007, doi:10.3200/JRLP.141.2.147-172) (lhle et al., 2017, doi:10.1159/000479680)

  6 months

Secondary Outcomes (14)

• Individual subtests of the COGTEL (Cognitive Telephone Screening Instrument)

  6 months

• D2-R test

  6 months

• Trail making test

  6 months

• Go/No-Go

  6 months

• International Matrix Test (Oldenburg)

  6 months

Study Arms (3)

Music practice

EXPERIMENTAL

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

Behavioral: Music practice

Psychomotor therapy

EXPERIMENTAL

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

Behavioral: Psychomotor therapy

Passive control group

NO INTERVENTION

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.

Interventions

Music practice BEHAVIORAL

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

Music practice

Psychomotor therapy BEHAVIORAL

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

Psychomotor therapy

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serious motor deficits
• Impaired/not-corrected hearing
• Serious physical and mental comorbidities
• Participation in physical or cognitive training over the last 12 months
• Maximum 5 years of official music education over the lifespan outside the school curriculum or during the last 3 years
• Intensive physical activity over the last 12 months (sports or body-mind exercises)
• Left-handed or ambidextrous
• 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.)

Sponsors & Collaborators

• School of Health Sciences Geneva: lead
• University Hospital, Geneva: collaborator
• University of Geneva, Switzerland: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (2)

CHUV: Centre Leenaards Memory Center

Lausanne, Canton of Vaud, 1011, Switzerland

Location

School of Health Sciences Geneva HES-SO

Geneva, 1206, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36747142 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clara E. James, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will receive the information that 2 interventions to improve cognitive function in Mild Cognitive Impairment will be compared and that assignment to the interventions is random for scientific reasons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 experimental conditions (Music practice vs. Psychomotor training) and 1 passive control condition

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 14, 2020
• Study Start: January 1, 2021
• Primary Completion: March 27, 2023
• Study Completion: May 27, 2023
• Last Updated: June 1, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After study completion (2022)
• Access Criteria: To be defined

Locations

CH (2)