- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07769099
Musical Training: Promoting Brain Function in Children Who Have Survived Brain Tumours
13 août 2026 mis à jour par: Dr Joyce Chung, The Hong Kong Polytechnic University
Efficacy of a Musical Training Programme in Promoting Neuroplasticity in Children Who Have Survived Brain Tumours: a Randomized Controlled Trial
This study aims to understand whether learning music can help improve brain function and quality of life in children who have recovered from brain tumours.
A total of 236 children will join the study.
Some of them will receive regular medical care, while others will take part in a music training program using the ukulele.
The music program will last for one year and includes both in-person group classes and online individual sessions.
The investigators will assess how well the children can think, remember, and focus before and after the training.
The investigators will also ask about their daily life and well-being.
This study hopes to show that music training can be a fun and helpful way to support recovery in childhood brain tumour survivors.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
This randomized controlled trial aims to determine the efficacy of musical training in promoting neuroplasticity and enhancing the quality of life in children who have survived brain tumours.
A total of 236 participants will be recruited from Hong Kong Children's Hospital and Children's Cancer Foundation centres.
Participants in the intervention group will receive 52 weeks of musical training, consisting of 36 face-to-face small group sessions and 16 online individual sessions, while the control group will receive usual care.
The ukulele, chosen for its light weight, simple chords, and cheerful sound, will be used as the training instrument due to its accessibility and appeal to children.
Neuroplasticity will be assessed using a battery of standardized instruments, including the Test of This study aims to explore whether musical training can help improve brain function and quality of life in children who have survived brain tumours.
A total of 236 children will be recruited and randomly assigned to either an intervention group or a control group.
The intervention group will receive 52 weeks of ukulele-based musical training, which includes 36 face-to-face group sessions held at The Hong Kong Polytechnic University and 16 online individual sessions conducted at home.
The control group will receive usual care only.
The ukulele was chosen for its light weight, simple chords, and child-friendly sound, making it ideal for young learners.
To support families who may not be familiar with online tools, the investigators will provide user guides, video tutorials, and technical support.
The study will assess participants' brain function-including nonverbal intelligence, attention, memory, processing speed, and executive functioning-as well as their daily functioning and quality of life using standardized tests and questionnaires.
These assessments will be conducted before and after the intervention and at follow-up.
The investigators hope the results will show that musical training is a fun and effective way to support the neurological and emotional recovery of children after brain tumour treatment.
Type d'étude
Interventionnel
Inscription (Estimé)
236
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Joyce Chung
- Numéro de téléphone: +852 27666322
- E-mail: okjoyce.chung@polyu.edu.hk
Lieux d'étude
-
-
-
Hong Kong, Hong Kong
- The Hong Kong Children's Hospital, Hong Kong
-
Contact:
- Vivian Yuen
- Numéro de téléphone: +852 35133193
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Completed cancer treatment at least 2 months previously,
- Aged 7-16 years,
- Able to speak Cantonese and read Chinese
- Have had no musical training since their cancer diagnosis
Exclusion Criteria:
- Have cancer recurrence or a second malignancy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: The intervention group will receive 52 weeks of musical training, including face-to-face and online.
musical training
|
52 weeks of musical training, consisting of (1) 36 weekly group based, face-to-face sessions, and (2) 16 weeks of weekly online individual sessions.
Each lasting 45 minutes to 1 hour.
|
|
Aucune intervention: Control
The control group will receive usual care for 52 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nonverbal Intelligence Score as Measured by the Test of Nonverbal Intelligence, Fourth Edition (TONI-4)
Délai: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
The Test of Nonverbal Intelligence, Fourth Edition (TONI-4) is a language-free measure of nonverbal intelligence, abstract reasoning, and problem-solving.The Index score (mean = 100, SD = 15) will be reported.
Higher scores indicate better nonverbal intelligence.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
|
Digit Span Score (Forward + Backward)
Délai: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Digit Span (Digits Forward + Digits Backward) assesses attention and working memory.
The total score will be reported.
Higher scores indicate better attention and working memory performance.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
|
Memory Score as Measured by the Hong Kong List Learning Test, Second Edition (HKLLT-2)
Délai: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
The Hong Kong List Learning Test, Second Edition (HKLLT-2) assesses verbal memory.
The total recall / delayed recall score will be reported.
Higher scores indicate better memory performance.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
|
Processing Speed / Executive Function as Measured by the Children's Color Trails Test (CCTT)
Délai: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
The Children's Color Trails Test (CCTT) assesses sustained attention, sequencing, and executive function.
Trail 1 involves connecting numbers (1-15) in sequence, while Trail 2 adds alternating between two colours.
Processing speed is estimated from Trail 1 time, while the interference index (Trail 2 minus Trail 1) reflects executive functions, including inhibitory control and cognitive flexibility.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
|
Executive Function as Measured by the Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Délai: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
The Behaviour Rating Inventory of Executive Function-2 is an assessment of executive function behaviours.
A Global Executive Composite (GEC) T-score (or specific index T-scores) will be given.
Higher T-scores mean more executive dysfunction.
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of life scores of the child participants
Délai: At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Measured by The Chinese version of the Paediatric Quality of Life Inventory (PedsQL)
|
At baseline, 12 months immediately after the completion of the intervention, and 6 months after the completion of the intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 octobre 2026
Achèvement primaire (Estimé)
30 mai 2029
Achèvement de l'étude (Estimé)
30 octobre 2029
Dates d'inscription aux études
Première soumission
10 août 2026
Première soumission répondant aux critères de contrôle qualité
13 août 2026
Première publication (Réel)
17 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-2025-673
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .