Orchestra in Class, a Novel Booster for Executive Functions and Brain Development in Young Primary School Children (ORBIT)

How to optimally stimulate the developing brain is still unclear. Executive functions (EF) exhibited substantially stronger far transfer effects in children who learned to play a musical instrument than in children who acquired other arts.

What is crucially lacking is a large-scale, long-term genuine randomized controlled trial (RCT) in cognitive neuroscience, comparing musical instrumental training (MIP) to another art form and a control group. Collected data of this proposal will allow, using machine learning, to build a data-driven multivariate model of children's interconnected brain and EF development over the first 2 years of their academic curriculum (6-8 years), with or without music or other art training.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Behavior; Functional Magnetic Resonance Imaging; Music; Development, Child; Brain Imaging; Executive Functions; Brain Plasticity; Interventions; Arts; Structural Brain Connectivity
• Intervention / Treatment: Behavioral: Orchestra in Class

Detailed Description

This cognitive neuroscience study, employing a randomized controlled trial (RCT), aims to investigate the potential cognitive and brain development benefits in young school children from two-year interventions: Orchestra in Class (OC, music practice, experimental group) compared with Visual Arts (VA, second experimental group) versus Standard Education (active control group (CG)). The CG will be offered six cultural outings per year (concerts, museums, theatres, etc.). Both nonverbal art interventions will be given weekly interventions for 1 hour and 30 minutes in school class sized groups. The VA groups serve to control for the influences of regular stimulating group interventions and homework, and also to compare specific effects in visual mode with the auditory mode in OC. The CG controls for overall child development and test-retest effects.

We plan to recruit 150 children aged 6-8 years from public elementary schools, ensuring a random and therefore equal distribution among the three groups. Data collection will involve annual comprehensive psychometric testing (baseline, after 1 year, after 2 years) of executive functions, i.e., far transfer and near transfer, musicality, drawing, academic achievement, and multimodal structural and functional magnetic resonance imaging (fMRI), including fMRI with auditory and visual domain working memory tasks.

By utilizing multivariate analyses and integrating behavioral and brain data through machine learning, we aim to create a data-driven model of the development of executive functions at the behavioral and brain levels in young children at the beginning of their school careers (6 to 8 years old), both without and with an enriched environment (musical practice versus visual arts)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara E James, PhD; Phone Number: +41225585419; Email: clara.james@hesge.ch
• Study Contact Backup: Name: Yohan Van De Looij, PhD; Phone Number: +41225586779; Email: yohan.vandelooij@hesge.ch

Study Locations

• Switzerland
  • Genève, Switzerland, 1206
    • Recruiting
    • Haute école de santé de Genève HES-SO
    • Contact: Clara James, PhD; Phone Number: 022 558 54 19; Email: clara.james@hesge.ch
    • Contact: Maxim Tingaud, MSc; Phone Number: 022 558 76 25; Email: maxim.tingaud@hesge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• School grade 3P/4P (3rd and 4th year of elementary school (6-8-year-old children)
• Right-handedness
• Sufficient Mastery of the French Language
• Able to give oral informed consent (child)
• Able to give written informed consent (parent)

Exclusion Criteria:

• Non-consent (children and or parents)
• Repeated or skipped a class with respect to standard curriculum
• Not corrected/severe hearing deficits
• Not corrected/severe vision deficits
• Severe neurodevelopmental disorders (eg. severe dyslexia, severe ADHD)
• Older than 7 at the beginning of the school year if 3P
• Older than 8 at the beginning of the school year if 4P
• Protocolled music instrumental practice in the preceding year
• Protocolled visual arts courses in the preceding year
• MRI incompatibility (physical or psychological)
• Psychometric battery incompatibility (psychological)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Culture; The children will receive six cultural outings per year (museums, concerts, theatre, etc.) and pass all measurements	Behavioral: Orchestra in Class; See arm/group descriptions; Other Names: Visual Arts
Experimental: Orchestra in Class; Children will receive music practice lessons in groups, "Orchestra in Class" (4 different string instruments, violin, viola, cello, double bass) in school class size groups over 2 full years. Interventions, given by 2 professional teachers per class, take place for 1 hour and 30 minutes per week, completed by daily homework (20-30 minutes).	Behavioral: Orchestra in Class; See arm/group descriptions; Other Names: Visual Arts
Experimental: Visual Arts; Children will receive visual arts lessons in school class size groups over 2 full years. Interventions, given by 2 professional teachers per class, take place for 1 hour and 30 minutes per week, completed by daily homework (20-30 minutes).	Behavioral: Orchestra in Class; See arm/group descriptions; Other Names: Visual Arts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working Memory	Working memory (WM) will be assessed by 3 tests: 2 fMRI tests: a visual and an auditory WM test (Vuontela et al., 2003) and the Digit Span Backward from the WISC V (Wechsler Intelligence Scale for Children; Wechsler, 2014). We expect the progress of the mean WM score to show the following evolution after 2 years: Orchestra in Class > Visual Arts > Passive Control Group	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional brain connectivity	Functional brain connectivity, measured with resting-state functional MRI (Leonardi,et al., 2013) We anticipate greater Functional Connectivity (FC) changes following the same gradient Orchestra in Class > Visual Arts > Passive Control Group In the following brain networks: The Default Mode Network (DMN), Central Executive Network (CEN) and Salience Network (SN)	2 years
Plasticity of gray matter brain volume	Gray matter brain plasticity, measured by T1-weighted MRI MP2RAGE (magnetization prepared 2 rapid acquisition gradient echoes; Marques & Gruetter, 2013) We expect greater gray matter volume change after 2 years according to the following gradient: Orchestra in Class > Visual Arts > Passive Control Group For the following brain areas: notably in a set of temporal (medial and lateral (auditory)), prefrontal, superior parietal areas, the basal ganglia (striatum), the cerebellum and the corpus callosum (supporting Working Memory, Executive Functions and attention)	2 years

Collaborators and Investigators

• Sponsor: School of Health Sciences Geneva
• Collaborators: University of Lausanne Hospitals; University of Geneva, Switzerland
• Investigators: Study Director: Clara James, PhD, HES-SO University of Applied Sciences and Arts Western Switzerland

Study record dates

Study Major Dates

• Study Start (Estimated): December 18, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 126645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the end of the project, the recoded data set (cleaned and anonymized excel and R file formats, matlab matrices, all scripts), the data codebook, references for the measurement instruments and all other relevant information related to the project (protocol, sampling, etc.) will be deposited at the Yareta (DLCM Data Life Cycle Management) platform for data sharing and reuse. Potential users will be informed of data availability by means of explicit mentions in publications (e.g., section "availability of data and material" in publications). The contact and identity information of the participants will never be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No