DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls

Completed · Not applicable

Conditions studied: Duchenne Muscular Dystrophy

In brief

Physicians seek a method to assess neuromuscular disease that is both non-invasive and quantifiable. Many patients do not tolerate standard current day assessment tools (such as needle electromyogram), and Electrical Impedance Myography (EIM) has the potential to serve as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful, these devices will allow for improved ability to diagnose neuromuscular disease and to assess disease progression or remission, allowing for better care of individual patients as well as for use in clinical trials, where improved outcome measures for neuromuscular diseases is being sought.

Key facts

Study ID

NCT01523964

Run by

Dart Therapeutics. LLC

People needed

92

Starts

2012-02-01

Expected to finish

2012-08-01

Last updated by the study team

2013-12-09

Who can join

Age: 3 and older, up to 12. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• DMD Subject Cohorts
• Male subjects
• Subjects with a chronologic age of 3 to 7 years inclusive for Cohort A, and 8 to 12 years inclusive for Cohort B
• Subjects with DMD diagnosed with mutational testing and/or absence of dystrophin on muscle biopsy
• Subjects with proximal pelvic girdle weakness (Gower's maneuver, difficulty with arising from floor and going up steps)
• Subjects who can walk 10 meters unassisted (ie, without braces, canes, or other aids)
• Subjects who are taking systemic corticosteroids and/or any other medication which, in the judgment of the investigator, could impact muscle strength or physical activity levels, must be on a stable dose for at least 4 weeks prior to initiation of study measurements
• Subjects who provide assent, as stipulated by IRB requirements, and whose parent/guardian signs an informed consent form
• Subjects who are willing and able to cooperate and comply with all protocol requirements and procedures
• Healthy Control Cohort
• Healthy males with normal neuromuscular examination
• Subjects with a chronologic age of 3 to 7 years inclusive for Cohort C, and 8 to 12 years inclusive for Cohort D
• Subjects who provide assent, as stipulated by IRB requirements, and whose parent/guardian signs an informed consent form
• Subjects who are willing and able to cooperate and comply with all protocol requirements and procedures

You may not qualify if…

• Subjects with daytime ventilatory dependence (non-invasive or tracheostomy)
• Subjects enrolled in a DMD therapeutic clinical trial concomitantly or within the past 4 weeks
• Subjects with any physical or mental condition which may, in the investigator's opinion, render the subject unable to complete the tasks of the study appropriately

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Massauchusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• The University of Texas Southwestern Medical Center-Dallas — Dallas, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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