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

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.

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

Up to 18 year

Sex eligibility

Male

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Duchenne Muscular Dystrophy:

Inclusion criteria

1. Age 0-18
2. Male
3. 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

1. Age over 18
2. Female
3. Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Skulpt, Inc.

Industry

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 19, 2015
Registry last updated: Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed