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

Skulpt

Status: Completed

Conditions: Duchenne Muscular Dystrophy

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT02340923

PED-003-2014

2R44NS073188 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 327 patients

Sex: Male

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

327 participants in 2 patient groups

Healthy Subjects

Description:

Healthy subjects aged 0-18 years old. Subjects cannot have a presence or past history of a neurological disorder or other disease that would be expected to substantially impact health.

Duchenne Muscular Dystrophy Subjects

Description:

Male subjects aged 0-18 years old with genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member. Additionally, subjects cannot have the presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.