NCT07362875 Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy
| NCT ID | NCT07362875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Myotonic Dystrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2025-05-15 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: * Cardiac pacemaker, defibrillator, metal implants, or other contraindications for MRI * Use of anabolic or catabolic agents within one year of entry * History of lumbar spine or leg surgery, lumbar radiculopathy, or peripheral neuropathy * BMI \> 35 because obesity compromises positioning on the MR scanner * Pregnancy * 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.
Contact & Investigator
Araya Puwanant, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT07362875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Myotonic Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07362875 currently recruiting?
Yes, NCT07362875 is actively recruiting participants. Contact the research team at Elizabeth.Hilber@Advocatehealth.org for enrollment information.
Where is the NCT07362875 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT07362875 clinical trial?
NCT07362875 is sponsored by Wake Forest University Health Sciences. The principal investigator is Araya Puwanant, MD at Wake Forest University Health Sciences. The trial plans to enroll 75 participants.