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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02340923

Enrollment

327

Registered

2015-01-19

Start date

2015-01-31

Completion date

2016-08-31

Last updated

2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Keywords

DMD, Duchenne Muscular Dystrophy, EIM

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

No minimum to 18 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Electrical Impedance Myography Measurements	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.

Countries

United States

Outcome results