A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
2 other identifiers
observational
327
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 11, 2016
August 1, 2016
1.4 years
December 3, 2014
August 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electrical Impedance Myography Measurements
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.
Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only
Study Arms (2)
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.
Eligibility Criteria
Duchenne Muscular Dystrophy Subjects
You may qualify if:
- \. Age 0-18
- \. Male
- \. Genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member.
You may not qualify if:
- \. Age over 18
- \. Female
- \. Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
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.
PMID: 31876124DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2014
First Posted
January 19, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2016
Study Completion
August 1, 2016
Last Updated
August 11, 2016
Record last verified: 2016-08