Electrical Impedance Myography and Ultrasound as Biomarkers of Duchenne Muscular Dystrophy (QED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Hospital Boston
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01491555
First received: December 5, 2011
Last updated: April 30, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

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
Study Population

This study will involve boys with DMD and healthy male controls.

Criteria

Inclusion criteria (DMD):

  1. Genetically established diagnosis of DMD
  2. Male, age 2 and up

Inclusion criteria (Control):

1. Male, age 2 and up

Exclusion criteria (DMD):

  1. Involvement in an ongoing clinical trial in DMD (outside of a natural history study)
  2. Presence of implanted pacemaker or other electrical device
  3. Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health

Exclusion criteria (control):

  1. Presence or past history of a neuromuscular disorder or other disease that substantially impacts health
  2. Presence of implanted pacemaker or other electrical device.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491555

Contacts
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

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Beth Israel Deaconess Medical Center
Investigators
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
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on September 30, 2014