Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07362875
Status
Recruiting
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Conditions

  • Myotonic Dystrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Jan 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Contractile muscle volume (CMV, cm3) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Elizabeth (Gracie) G Hilber
[email protected]
336-716-4163
Constance Linville
[email protected]
704-355-2000

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Wake Forest University Health Sciences· Winston-Salem, NC

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