Music Intervention for Brain-Heart Disease in Myotonic Dystrophy Type 1 (DM1)
NCT ID: NCT06809049
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2025-03-25
2025-12-31
Brief Summary
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Researchers will compare the results of physical and cognitive assessments for each participant to assessments from baseline after 10 weeks of weekly music sessions. Qualitative measures (questionnaires and focus groups) will inform the feasibility of this intervention for this population. The main questions this study aims to answer are:
* Are weekly music education sessions feasible for children with DM1?
* Are weekly music education sessions tolerable for children with DM1?
Participants will:
* Attend 45-minute-long music sessions once weekly for 10 weeks.
* Attend two clinic visits for cognitive and physical assessments.
* Provide blood, saliva, stool and urine samples.
* Use wearable devices both at-home and during music sessions.
* Parents/caregivers of participants will complete questionnaires and participate in three focus groups.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Music Intervention
All participants will receive weekly Dalcroze music education sessions.
Dalcroze music education
Dalcroze is a type of music education which focuses on free and improvised movement, as well as structure and choreographed sequences. It has been successfully applied to similar populations as an effective, accessible, and sustainable intervention. We hope to use Dalcroze music education to employ a holistic approach to improve the brain-heart symptoms of children with congenital DM1.
Interventions
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Dalcroze music education
Dalcroze is a type of music education which focuses on free and improvised movement, as well as structure and choreographed sequences. It has been successfully applied to similar populations as an effective, accessible, and sustainable intervention. We hope to use Dalcroze music education to employ a holistic approach to improve the brain-heart symptoms of children with congenital DM1.
Eligibility Criteria
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Inclusion Criteria
* Participants willing to stay on stable medication from the day of screening to end of study.
Exclusion Criteria
* Participant is non-verbal.
* Failure to provide signed informed consent by participant or designated decision maker (i.e. parent, legal guardian or power of attorney).
* Failure to provide signed informed consent by parents/caregivers for dyad participation.
* Participant is not a resident of Canada, due to risk of attrition.
* Patients for whom - in the opinion of the investigator - it would not be safe to participate in the study.
6 Years
18 Years
ALL
No
Sponsors
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University of Ottawa
OTHER
Hanns Lochmuller
OTHER
Responsible Party
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Hanns Lochmuller
Senior Scientist
Locations
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Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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CFREF-2022-00007
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BHI 23-118
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24/143X
Identifier Type: -
Identifier Source: org_study_id
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