Trial record 3 of 5 for:    Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dart Therapeutics. LLC
ClinicalTrials.gov Identifier:
NCT01523964
First received: January 30, 2012
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

Physicians seek a method to assess neuromuscular disease that is both non-invasive and quantifiable. Many patients do not tolerate standard current day assessment tools (such as needle electromyogram), and Electrical Impedance Myography (EIM) has the potential to serve as a non-invasive, quantifiable, diagnostic tool for neuromuscular disease. If successful, these devices will allow for improved ability to diagnose neuromuscular disease and to assess disease progression or remission, allowing for better care of individual patients as well as for use in clinical trials, where improved outcome measures for neuromuscular diseases is being sought.


Condition Intervention
Duchenne Muscular Dystrophy
Other: Testing with EIM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase I, Multi-Center, Controlled, Prospective Correlative Study of Electrical Impedance Myography in Males With Duchenne Muscular Dystrophy and In Healthy Males

Resource links provided by NLM:


Further study details as provided by Dart Therapeutics. LLC:

Primary Outcome Measures:
  • Number of Subjects With an Adverse Event. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Adverse events will be assessed during the time the subject is enrolled in the trial.


Enrollment: 92
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DMD subject ages 3-7 inclusive
Young DMD Testing with EIM
Other: Testing with EIM
DMD subject ages 8-12 inclusive
Older DMD Testing with EIM
Other: Testing with EIM
Healthy Control ages 3-7 inclusive
Young Healthy Testing with EIM
Other: Testing with EIM
Healthy Control ages 8-12 inclusive
Older Healthy Testing with EIM
Other: Testing with EIM

Detailed Description:

Healthy subjects and subjects with DMD will be screened during Visit 1. Screening evaluations will establish eligibility and will include a medical history, abbreviated physical examination, vital signs (blood pressure, temperature, pulse, and respirations), and weight. Eligible subjects will provide assent, as stipulated by Institutional Review Board (IRB) requirements, and a parent/guardian will sign an informed consent, after which the subject will be considered enrolled.

Subjects will be enrolled into 4 study cohorts for a total of approximately 90 subjects. Allocation into these cohorts is planned due to considerations regarding the effect of age on outcomes.

Visit 2, Study Assessments, may take place on the day of Visit 1 screening evaluations. If the subject cannot complete study assessments on the same day, the subject may return and complete Visit 2 evaluations within approximately 24 hours of the end of Visit 1.

Visit 2 assessments will include morphological testing of muscle length and girth, skin fat measurement, Clinical Assessments (6-Minute Walk Test [6MWT], North Star Ambulatory Assessment, timed function tests, dynamometry), and 3 phases of Device Performance testing. Phase 1 Device Performance testing will be done by each of 2 trained raters (Rater A and Rater B) from the research site, designated to perform the Device Performance testing on all subjects at their respective site. At least 10 minutes after completion of the first assessments, Phase 2 Device Performance testing will be repeated by Rater A. Upon completion of the Phase 2 Device Performance testing, the subjects will proceed with Clinical Assessments performed by a physical therapist. Following Clinical Assessments, Phase 3 Device Performance testing will be performed by Rater B.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

DMD Subject Cohorts

  • Male subjects
  • Subjects with a chronologic age of 3 to 7 years inclusive for Cohort A, and 8 to 12 years inclusive for Cohort B
  • Subjects with DMD diagnosed with mutational testing and/or absence of dystrophin on muscle biopsy
  • Subjects with proximal pelvic girdle weakness (Gower's maneuver, difficulty with arising from floor and going up steps)
  • Subjects who can walk 10 meters unassisted (ie, without braces, canes, or other aids)
  • Subjects who are taking systemic corticosteroids and/or any other medication which, in the judgment of the investigator, could impact muscle strength or physical activity levels, must be on a stable dose for at least 4 weeks prior to initiation of study measurements
  • Subjects who provide assent, as stipulated by IRB requirements, and whose parent/guardian signs an informed consent form
  • Subjects who are willing and able to cooperate and comply with all protocol requirements and procedures

Healthy Control Cohort

  • Healthy males with normal neuromuscular examination
  • Subjects with a chronologic age of 3 to 7 years inclusive for Cohort C, and 8 to 12 years inclusive for Cohort D
  • Subjects who provide assent, as stipulated by IRB requirements, and whose parent/guardian signs an informed consent form
  • Subjects who are willing and able to cooperate and comply with all protocol requirements and procedures

Exclusion Criteria:

  • Subjects with daytime ventilatory dependence (non-invasive or tracheostomy)
  • Subjects enrolled in a DMD therapeutic clinical trial concomitantly or within the past 4 weeks
  • Subjects with any physical or mental condition which may, in the investigator's opinion, render the subject unable to complete the tasks of the study appropriately
  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: NCT01523964

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massauchusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
United States, Texas
The University of Texas Southwestern Medical Center-Dallas
Dallas, Texas, United States, 75220
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Dart Therapeutics. LLC
  More Information

No publications provided

Responsible Party: Dart Therapeutics. LLC
ClinicalTrials.gov Identifier: NCT01523964     History of Changes
Other Study ID Numbers: CMD-001
Study First Received: January 30, 2012
Results First Received: August 9, 2013
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dart Therapeutics. LLC:
DMD
EIM
Duchenne Muscular Dystrophy
electrical impedance myography

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 16, 2014