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

Skulpt, Inc.5 sites in 1 country327 target enrollmentJanuary 2015

ConditionsDuchenne Muscular Dystrophy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Duchenne Muscular Dystrophy
Sponsor: Skulpt, Inc.
Enrollment: 327
Locations: 5
Primary Endpoint: Electrical Impedance Myography Measurements
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

August 2016

Last Updated

9 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Skulpt, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.

Outcomes

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.