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Development, ChildORBITNCT05912270

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

A study testing Orchestra in Class in people with Development, Child and Executive Functions, run by School of Health Sciences Geneva at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 6 to 8 yearsHealthy volunteers can take part
What is being tested?
Orchestra in Class
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSwitzerland
Study dates
18 Dec 2023to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clara E James, PhD contact

+41225585419

clara.james@hesge.ch

Yohan Van De Looij, PhD contact

+41225586779

yohan.vandelooij@hesge.ch

Switzerland1 site, 1 recruiting

  • Haute école de santé de Genève HES-SO

    Geneva, 1206

    Clara James, PhD, 022 558 54 19, clara.james@hesge.ch

    Maxim Tingaud, MSc, 022 558 76 25, maxim.tingaud@hesge.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the 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)

Being tested
Orchestra in Class
Medical subject headings
Arts syndrome, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orchestra in ClassBehavioural

    Also called Visual Arts

    See arm/group descriptions

Study groups in NCT05912270
Study groupRoleWhat they receive
Orchestra in ClassExperimentalChildren 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).
Receives: Behavioral: Orchestra in Class
Visual ArtsExperimentalChildren 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).
Receives: Behavioral: Orchestra in Class
CulturePlacebo comparatorThe children will receive six cultural outings per year (museums, concerts, theatre, etc.) and pass all measurements
Receives: Behavioral: Orchestra in Class

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (2)

  1. 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)

    Measured: 2 years

  2. 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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start18 Dec 2023 (estimated)
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912270
Sponsor's protocol ID
126645
Acronym
ORBIT
Status last verified
Dec 2023
First submitted
30 May 2023
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • James CE, Tingaud M, Laera G, Guedj C, Zuber S, Diambrini Palazzi R, Vukovic S, Richiardi J, Kliegel M, Marie D. Cognitive enrichment through art: a randomized controlled trial on the effect of music or visual arts group practice on cognitive and brain development of young children. BMC Complement Med Ther. 2024 Apr 4;24(1):141. doi: 10.1186/s12906-024-04433-1.

    PubMed 38575952

Questions about this trial

What is this clinical trial studying?

A study testing Orchestra in Class in people with Development, Child and Executive Functions, run by School of Health Sciences Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clara E James, PhD (+41225585419, clara.james@hesge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Working Memory (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912270, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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