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

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

Patrocinadores

Patrocinador principal: Skulpt, Inc.

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente Skulpt, Inc.
Resumen breve

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.

Estado general Completed
Fecha de inicio January 2015
Fecha de Terminación August 2016
Fecha de finalización primaria June 2016
Tipo de estudio Observational [Patient Registry]
Resultado primario
Medida Periodo de tiempo
Electrical Impedance Myography Measurements Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only
Inscripción 327
Condición
Elegibilidad

Método de muestreo: Probability Sample

Criterios:

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.

Género: Male

Edad mínima: N/A

Edad máxima: 18 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones:
Children's Hospital Colorado | Aurora, Colorado, 80045, United States
Boston Children's Hospital | Boston, Massachusetts, 02115, United States
Skulpt, Inc. | Boston, Massachusetts, 02210, United States
St. Louis Children's Hospital | St. Louis, Missouri, 63310, United States
Cincinnati Children's Hospital | Cincinnati, Ohio, 45229, United States
Ubicacion Paises

United States

Fecha de verificación

August 2016

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Healthy Subjects

Descripción: 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.

Etiqueta: Duchenne Muscular Dystrophy Subjects

Descripción: 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.

Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Cross-Sectional

Fuente: ClinicalTrials.gov