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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02340923
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Skulpt, Inc.

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.

Condition or disease
Duchenne Muscular Dystrophy

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Study Type : Observational [Patient Registry]
Actual Enrollment : 327 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016


Group/Cohort
Healthy Subjects
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
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Duchenne Muscular Dystrophy Subjects
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340923


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Skulpt, Inc.
Boston, Massachusetts, United States, 02210
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63310
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Skulpt, Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Skulpt, Inc.
ClinicalTrials.gov Identifier: NCT02340923    
Other Study ID Numbers: PED-003-2014
2R44NS073188 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Skulpt, Inc.:
DMD
Duchenne Muscular Dystrophy
EIM
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked