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

Skulpt, Inc.327 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

327

Conditions

Duchenne Muscular Dystrophy

Eligibility

Sex: MALEMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Children's Hospital Colorado

Aurora, Colorado, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Skulpt, Inc.

Boston, Massachusetts, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Electrical Impedance Myography Measurements

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.

Time frame: Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only

Data from ClinicalTrials.gov

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