Actively Recruiting
Music Intervention for Brain-Heart Disease in Children with Myotonic Dystrophy Type 1 (DM1)
Led by Hanns Lochmuller · Updated on 2026-02-19
13
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hanns Lochmuller
Lead Sponsor
U
University of Ottawa
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a music and movement intervention for children aged 6 to 18 with congenital or infantile-onset myotonic dystrophy type 1 (DM1). This study aims to show that weekly music education sessions are feasible and tolerable for these children and to explore potential improvements in brain and heart symptoms related to DM1. The study also seeks to identify brain-heart biomarkers and outcome measures using biological samples and wearable devices to support future research. Participants will attend weekly 45-minute music and movement sessions for 10 weeks, based on an adaptive music-education method called Dalcroze eurhythmics, which involves free and structured movement. All participants receive this intervention. Biological samples such as blood, saliva, stool, and urine will be collected. Wearable devices including accelerometers, EEG headbands, and ECG chest straps will be used both at home and during sessions. Parents and caregivers will complete questionnaires and join focus groups to provide feedback. During the study, participants will undergo physical and cognitive assessments at baseline and one week after the final session. These include tests of physical performance, memory, attention, executive function, mood, quality of life, sleep quality, and cardiac conduction. Attendance and qualitative feedback from parents/caregivers will be closely monitored to assess feasibility. The study lasts for about 10 weeks of intervention, plus assessment visits, with safety and satisfaction tracked throughout.
CONDITIONS
Brief Title
Music Intervention for Brain-Heart Disease in Myotonic Dystrophy Type 1 (DM1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants between 6 and 18 years old
- Genetically confirmed congenital or infantile-onset myotonic dystrophy type 1 (DM1)
- Willingness to stay on stable medication from screening to end of study
You will not qualify if you...
- Insufficient English skills to complete assessments and questionnaires
- Non-verbal participants
- Lack of signed informed consent by participant or legal guardian
- Lack of signed informed consent by parents/caregivers for dyad participation
- Participants not residing in Canada
- Participants considered unsafe to participate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants attend weekly music and movement education sessions designed to improve brain-heart symptoms associated with congenital DM1.
Weekly visits for 10 weeks
Duration - 1 week
Participants complete assessments and questionnaires to evaluate changes in physical performance, cognitive function, mood, quality of life, sleep, and cardiac health one week after the final music session.
1 visit (in-person) and additional monitoring with wearable devices over 7 days
Trial Site Locations
Total: 1 location
1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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