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A Device for Rapid, Painless, Bedside Muscle Evaluation of Children

key information

study id #: NCT02340923

condition: Duchenne Muscular Dystrophy

status: completed


The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT02340923

last updated: November 22, 2018

study details

start date: January 2015

estimated completion: June 2016

size / enrollment: 327

primary outcomes:

  • Electrical Impedance Myography Measurements [ Time Frame: Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only ]
    Up to 11 muscles will be measured using EIM technology. These muscles include: Right Lateral Deltoid, Right Biceps, Right Triceps, Right Wrist Flexors, Right Wrist Extensors, Right Vastus Lateralis, Right Tibialis Anterior, Right Gastrocnemius, Right Gluteus Medius, Right Biceps Femoris, and Right Thoracic Parapinal.

inclusion criteria:

• Eligible Sexes:

• Age 0-18
• Male
• Genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member.

exclusion criteria:
• Age over 18
• Female
• Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.

study contacts

sponsor: Skulpt, Inc.

trial center locations: United States