Actively Recruiting

Phase Not Applicable
Age: 6Years - 18Years
All Genders
ID06809049

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

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

Follow-up

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

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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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