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

Magnetic Resonance Imaging Clinical Trial

— ORBIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912270
• Other study ID #: 126645
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: December 2023
• Source: School of Health Sciences Geneva
• Contact: Clara E James, PhD
• Phone: +41225585419
• Email: clara.james[@]hesge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Behavior
• Brain Imaging
• Development, Child
• Executive Functions
• Functional Magnetic Resonance Imaging
• Magnetic Resonance Imaging
• Music

Intervention

Behavioral:
• Orchestra in Class
See arm/group descriptions

Locations

Country	Name	City	State
Switzerland	Haute école de santé de Genève HES-SO	Genève

Sponsors (3)

Lead Sponsor	Collaborator
School of Health Sciences Geneva	University of Geneva, Switzerland, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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