A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
NCT ID: NCT02340923
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
327 participants
OBSERVATIONAL
2015-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 2\. Female
* 3\. Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.
18 Years
MALE
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Skulpt, Inc.
INDUSTRY
Responsible Party
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Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Skulpt, Inc.
Boston, Massachusetts, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Countries
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References
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Leitner ML, Kapur K, Darras BT, Yang M, Wong B, Dalle Pazze L, Florence J, Buck M, Freedman L, Bohorquez J, Rutkove S, Zaidman C. Electrical impedance myography for reducing sample size in Duchenne muscular dystrophy trials. Ann Clin Transl Neurol. 2020 Jan;7(1):4-14. doi: 10.1002/acn3.50958. Epub 2019 Dec 25.
Other Identifiers
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PED-003-2014
Identifier Type: -
Identifier Source: org_study_id
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