Clinical trial NCT02754908: Effectiveness of Musical Training in Children Surviving Brain Tumours
Official title: Effectiveness of Musical Training in the Improvement of the Neurocognitive Function and Psychological Well-being of Children Surviving Brain Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Child
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.

Detailed description: Children surviving brain tumours have the highest risk of suffering neurocognitive late effects, such as impairment of intellectual development and deficits in attention and concentration, working memory, processing speed and executive function. Such effects severely affect their levels of academic achievement, psychosocial function and quality of life. Musical training is considered to have potential for treating neurocognitive impairment,mostly because the extensive brain networks engaged in musical training can induce substantial neuroplasticity changes in cortical and subcortical regions of motor, auditory and speech processing networks. A review of musical training for neuro-rehabilitation revealed that it can enhance motor recovery and neuroplasticity after stroke and improve motor deficits observed in Parkinson's disease. A growing body of evidence points to the beneficial effects of musical training on the cognitive development of children. The results of a longitudinal study on the effects of musical training on children's brain and cognitive development demonstrated that such training results in long-term enhancement of visualspatial, verbal and mathematical performance. Moreover, engaging in musical practice in childhood predicts academic performance and IQ at the university level. Thus, there appears to be some support for the effects of music lessons on intellectual development.

Nevertheless, although musical training is popular and is considered to be a beneficial intervention in the treatment of neurocognitive impairment, longitudinal studies that examine the efficacy of music-making in clinical settings are limited. Importantly, there is to date no study that examines the effects of musical training on induction of neuroplasticity in childhood cancer survivors with neurocognitive impairment. There is an imperative need for rigorous empirical scrutiny of the ability of musical training, in particular, to achieve neuroplasticity and thus promote the cognitive function and psychological well-being of children surviving brain tumours.

Eligibility criteria: Inclusion Criteria:

* surviving germ cell tumours of the brain
* be aged from 7 to 19 years
* be able to speak Cantonese and read Chinese
* have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
* have completed treatment for at least two months

Exclusion Criteria:

* have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
* with evidence of cancer recurrence or second malignancy in their medical records

Primary outcomes:
measure: Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group
timeFrame: 12 month follow-up
Secondary outcomes:
measure: neurocognitive function at baseline between intervention and control group
timeFrame: baseline
measure: self-esteem at baseline between intervention and control group
timeFrame: baseline
measure: Change in self-esteem from baseline at 6 month follow-up between intervention and control group
timeFrame: 6 month follow-up
measure: Change in self-esteem from baseline at 12 month follow-up between intervention and control group
timeFrame: 12 month follow-up
measure: quality of life at baseline between intervention and control group
timeFrame: baseline
measure: Change in quality of life from baseline at 6 month follow-up between intervention and control group
timeFrame: 6 month follow-up
measure: Change in quality of life from baseline at 12 month follow-up between intervention and control group
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ho Cheung William Li
role: PRINCIPAL_INVESTIGATOR
References: