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

NCT ID: NCT02340923

Last Updated: 2016-08-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Duchenne Muscular Dystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Skulpt, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Skulpt, Inc.

Boston, Massachusetts, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 31876124 (View on PubMed)

Other Identifiers

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2R44NS073188

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PED-003-2014

Identifier Type: -

Identifier Source: org_study_id

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