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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05912270
Acronym
ORBIT
Enrollment
150
Registered
2023-06-22
Start date
2023-12-18
Completion date
2027-04-30
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arts, Behavior, Brain Imaging, Brain Plasticity, Development, Child, Executive Functions, Functional Magnetic Resonance Imaging, Interventions, Magnetic Resonance Imaging, Music, Structural Brain Connectivity

Brief 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.

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)

Interventions

BEHAVIORALOrchestra in Class

See arm/group descriptions

Sponsors

University of Geneva, Switzerland
CollaboratorOTHER
University of Lausanne Hospitals
CollaboratorOTHER
School of Health Sciences Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Orchestra in Class is the first Experimental Condition, compared to Visual Arts (second Experimental Condition) and an active Control Group that will receive 6 cultural outings per year. We will present the study to the participants as a comparison between the two art interventions and a cultural intervention.

Intervention model description

The study is a 1) block-randomized, 2) 3-arm, 3) open, 4) monocentric (primary schools in Geneva) 5) national (Switzerland) 6) intervention study.

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Working Memory2 yearsWorking 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

Secondary

MeasureTime frameDescription
Plasticity of gray matter brain volume2 yearsGray 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)
Functional brain connectivity2 yearsFunctional 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)

Countries

Switzerland

Contacts

Primary ContactClara E James, PhD
clara.james@hesge.ch+41225585419
Backup ContactYohan Van De Looij, PhD
yohan.vandelooij@hesge.ch+41225586779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026