Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy
Key facts
- Who runs it
- Wake Forest University Health Sciences
- Where
- Winston-Salem, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 75 people, planned
- Started
- 15 May 2025
- Expected to end
- May 2029
- Type of study
- Observational, 2 groups
- Record updated
- 23 January 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- DM subjects
- Age 18 - 65 years
- Diagnosis of DM1 or DM2 by clinical or genetic criteria. If DM1 or DM2 was diagnosed by clinical criteria, a first-degree relative must have genetic testing confirmation and sign a genetic consent form to release their genetic information
- Clinically affected, as defined by muscle weakness or myotonia
- Ambulate independently (a walker is not permitted)
- Able to provide informed consent for participation in the study; Control subjects
- Age 18 - 65 years old
- Healthy as defined by no significant medical or neurological conditions
- Able to provide informed consent for participation in the study
Who cannot take part
- For muscle biopsy, history of bleeding disorders or on anticoagulation. Subjects taking nonsteroidal anti- inflammatory agents will be asked to discontinue these medications 7 days prior to muscle biopsy
- Cardiac pacemaker, defibrillator, metal implants, or other contraindications for MRI
- History of lumbar spine or leg surgery, lumbar radiculopathy, or peripheral neuropathy
- Use of anabolic or catabolic agents within one year of entry
- BMI > 35 because obesity compromises positioning on the MR scanner
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Wake Forest University Health SciencesWinston-Salem, United StatesContact: Elizabeth (Gracie) G HilberTaking people
About the trial
What the trial wants to find out
Myotonic dystrophy (dystrophia myotonica; DM), the most prevalent form of muscular dystrophy in adults, is characterized by progressive myopathy, myotonia, and multi-systemic involvement. DM causes severe disability and profoundly affects the patient's quality of life. Currently, no effective treatments are available that alter the course of the disease, but ongoing clinical trials are underway.
The 2 groups in the trial
- DM subjects
1. Age 18 - 65 years 2. Diagnosis of DM1 or DM2 by clinical or genetic criteria. If DM1 or DM2 was diagnosed by clinical criteria, a first-degree relative must have genetic testing confirmation and sign a genetic consent form to release their genetic information. 3. Clinically affected, as defined by muscle weakness or myotonia 4. Ambulate independently (a walker is not permitted) 5. Able to provide informed consent for participation in the study
- Control subjects
1. Age 18 - 65 years old 2. Healthy as defined by no significant medical or neurological conditions 3. Able to provide informed consent for participation in the study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy (DeQoDE-DM)
- Fit questions
- Built from NCT07362875, who can take part
- Record updated
- 23 January 2026