Electrical Impedance Myography and Ultrasound as Biomarkers of Duchenne Muscular Dystrophy (QED)
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ClinicalTrials.gov Identifier: NCT01491555 |
Recruitment Status
:
Completed
First Posted
: December 14, 2011
Last Update Posted
: March 24, 2016
|
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Researchers at Children's Hospital Boston Neurology Department invite children to participate in a new research study. Researchers are looking for boys ages 2 - 30 with Duchenne Muscular Dystrophy (DMD) and healthy boys ages 2 - 30 (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 participants are interested or would like to learn more about the study, please call Lavanya Madabusi at 617-919-3554 or Lavanya.Madabusi@childrens.harvard.edu. All inquiries will be kept strictly confidential.
Condition or disease |
---|
Duchenne Muscular Dystrophy |
Study Type : | Observational |
Actual Enrollment : | 73 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Electrical Impedance Myography and Ultrasound as Biomarkers of Duchenne Muscular Dystrophy |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Group/Cohort |
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DMD patients
35 boys ages 2 through 30 with DMD
|
Control Group
35 healthy boys ages 2 through 30
|
- The rate of decline of DMD patients versus normal subjects as assessed by EIM and quantitative ultrasound [ Time Frame: up to 45 months ]With the successful completion of this aim, the investigators will establish that alterations in both EIM and QUS provide meaningful surrogate measures of disease progression in DMD.
- The rate of decline of DMD patients versus normal subjects as assessed by handheld dynamometry, 6-minute walk, and other functional tests. [ Time Frame: up to 45 months ]With the successful completion of this aim, the investigators will establish that alterations in functional assessments may provide additional meaningful surrogate measures of disease progression in DMD.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion criteria (DMD):
- Genetically or histologically established diagnosis of DMD
- Male, age 2 - 30
Inclusion criteria (Control):
1. Male, age 2 - 30
Exclusion criteria (DMD):
- 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.

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): NCT01491555
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Basil Darras, MD | Boston Children’s Hospital | |
Principal Investigator: | Seward Rutkove, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Basil Darras, Basil Darras, M.D., Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT01491555 History of Changes |
Other Study ID Numbers: |
IRB-P00001218 |
First Posted: | December 14, 2011 Key Record Dates |
Last Update Posted: | March 24, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Basil Darras, Children's Hospital Boston:
Duchenne Muscular Dystrophy DMD controls EIM QUS |
Additional relevant MeSH terms:
Muscular Dystrophies Muscular Dystrophy, Duchenne Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked |