Haute école de santé de Genève HES-SO
Geneva, 1206, Switzerland
Location status: Recruiting
Location contact
Clara James, PhD
CONTACT
Maxim Tingaud, MSc
CONTACT
NCT Number: NCT05912270
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.
Interested in participating?
Request Info6 year–8 year
All sexes
Interventional
Not applicable
Geneva, 1206, Switzerland
Location status: Recruiting
Clara James, PhD
CONTACT
Maxim Tingaud, MSc
CONTACT
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)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See arm/group descriptions
Other names: Visual Arts
Time frame: 2 years
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
Time frame: 2 years
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)
Time frame: 2 years
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)
Contact information is provided by the study sponsor or research team.
Clara E James, PhD
CONTACT
Yohan Van De Looij, PhD
CONTACT
School of Health Sciences Geneva
Other
Acronym: ORBIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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