Electrical Impedance Myography and Ultrasound as Biomarkers of Duchenne Muscular Dystrophy (QED)
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Purpose
Researchers at Children's Hospital Boston Neurology Department invite children to participate in a new research study. Researchers are looking for boys age 2 and up with Duchenne Muscular Dystrophy (DMD) and healthy boys age 2 and up(without any nerve or muscle concerns) to serve as controls. The study is evaluating a new technique that will test nerve and muscle function. The testing is all pain free.
Children participating in the study will come in for 10 visits over two years. Visits will take place every month at first, then less often for the remaining visits. The tests for the study itself take approximately 2hours. If you are interested or would like to learn more about the study, please call Rebecca Parad at 617-355-2752 or Rebecca.Parad@childrens.harvard.edu. All inquiries will be kept strictly confidential.
| Condition |
|---|
|
Duchenne Muscular Dystrophy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Electrical Impedance Myography and Ultrasound as Biomarkers of Duchenne Muscular Dystrophy |
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2012 |
| Groups/Cohorts |
|---|
|
DMD patients
35 boys age 2 and over with DMD
|
|
Control Group
35 healthy boys age 2 and up
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
This study will involve boys with DMD and healthy male controls.
Inclusion criteria (DMD):
- Genetically established diagnosis of DMD
- Male, age 2 and up
Inclusion criteria (Control):
1. Male, age 2 and up
Exclusion criteria (DMD):
- Involvement in an ongoing clinical trial in DMD (outside of a natural history study)
- Presence of implanted pacemaker or other electrical device
- Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health
Exclusion criteria (control):
- Presence or past history of a neuromuscular disorder or other disease that substantially impacts health
- Presence of implanted pacemaker or other electrical device.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01491555
| Contact: Lavanya Madabusi, BA | 617-919-3554 | lavanya.madabusi@childrens.harvard.edu | |
| Contact: Nicole Visyak, MS, MA | 857-218-4677 | nicole.visyak@childrens.harvarad.edu |
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Basil Darras, MD | Children's Hospital Boston | |
| Principal Investigator: | Seward Rutkove, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01491555 History of Changes |
| Other Study ID Numbers: | IRB-P00001218 |
| Study First Received: | December 5, 2011 |
| Last Updated: | April 30, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
Duchenne Muscular Dystrophy DMD controls EIM QUS |
Additional relevant MeSH terms:
|
Muscular Dystrophies Muscular Dystrophy, Duchenne Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases |
Muscular Disorders, Atrophic Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015