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

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340923
• Other study ID #: PED-003-2014
• Secondary ID: 2R44NS073188
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: August 10, 2016
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Skulpt, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Skulpt, Inc.	Boston	Massachusetts
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	St. Louis Children's Hospital	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Skulpt, Inc.	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only	No