Actively Recruiting
Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy (DeQoDE-DM)
Led by Wake Forest University Health Sciences · Updated on 2026-01-23
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Myotonic dystrophy (DM) is the most common type of muscular dystrophy in adults, causing progressive muscle weakness, myotonia, and affecting multiple body systems. This condition leads to severe disability and significantly impacts patients' quality of life. Currently, there are no effective treatments that change the disease course, so researchers are exploring new ways to better understand and monitor DM progression using non-invasive methods. This research evaluates the use of Quantitative Magnetic Resonance Imaging (qMRI) as a non-invasive biomarker to study muscle structure and disease severity in people with DM. Traditional muscle biopsies to assess disease have been invasive and inefficient for long-term monitoring. The study compares muscle imaging findings with clinical signs and RNA splicing outcomes in DM patients, aiming to establish qMRI as a useful tool for future clinical trials and drug development. Participants include adults aged 18 to 65 with DM or healthy controls. They will undergo various muscle function tests, strength measurements, and physical performance assessments, along with MRI scans to measure muscle volume and fat content. Researchers will analyze these data to understand muscle changes and their relationship to disease severity. The study will monitor participants at baseline to collect this detailed information, contributing to improved disease assessment methods in DM.
CONDITIONS
Brief Title
Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Diagnosis of DM1 or DM2 by clinical or genetic criteria; if diagnosed clinically, a first-degree relative must have genetic confirmation and consent to share that information
- Clinically affected by muscle weakness or myotonia
- Able to walk independently without a walker
- Able to provide informed consent
- Healthy adults aged 18 to 65 years for control group
- No significant medical or neurological conditions for control group
- Able to provide informed consent for control group
You will not qualify if you...
- Having a cardiac pacemaker, defibrillator, metal implants, or other MRI contraindications
- Use of anabolic or catabolic agents within one year before the study
- History of lumbar spine or leg surgery, lumbar radiculopathy, or peripheral neuropathy
- Body mass index over 35
- Pregnancy
- History of bleeding disorders or current anticoagulation if undergoing muscle biopsy
- Use of nonsteroidal anti-inflammatory drugs within 7 days before muscle biopsy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo comprehensive muscle imaging and clinical assessments to characterize muscle structure and function.
1 visit (in-person)
Duration - Up to study completion in May 2029
Participants are observed to evaluate the relationship between imaging measures and clinical outcomes over time.
Follow-up visits may occur as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
E
Elizabeth (Gracie) G Hilber
C
Constance Linville
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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