Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Seward Rutkove, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT02104921
First received: March 31, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

This study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.


Condition
Amyotrophic Lateral Sclerosis
Muscular Dystrophy
Radiculopathy
Myopathy
Polyneuropathy and Mononeuropathies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Quantitative ultrasound data, including quantified grayscale data and backscattered acoustic data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Ultrasound data will be collected on multiple muscles in each person. The images will then be quantified using either 1. A grayscale technique in which the images themselves are analyzed via standard image software (e.g., Adobe Photoshop) as to level of echo intensity in a pre-specific region of interest or 2. the raw quantified backscatter data is captured by the transducer, expressed as a unit of power, in the same pre-specified area of interest


Estimated Enrollment: 240
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neuromuscular Disease Patients
Amyotrophic lateral sclerosis patients, myopathy patients, muscular dystrophy patients, myasthenia gravis patients, radiculopathy patients, mononeuropathy patients
Healthy volunteers

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with any neuromuscular disorder (i.e. primary nerve or muscle disease), both localized and generalized, producing some degree of weakness or disability.

Criteria

Inclusion Criteria:

  • History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.

Exclusion Criteria:

  • Multiple generalized neuromuscular conditions.
  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: NCT02104921

Contacts
Contact: Sung Lim 617-667-3053 syim@bidmc.harvard.edu
Contact: Alex Mijailovic 617-667-3053 amijailo@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sung Yim    617-667-3015    syim@bidmc.harvard.edu   
Principal Investigator: Seward B Rutkove, MD         
Sub-Investigator: Courtney McIlduff, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Seward Rutkove, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02104921     History of Changes
Other Study ID Numbers: 2K24NS060951
Study First Received: March 31, 2014
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Polyneuropathies
Central Nervous System Diseases
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Mononeuropathies
Muscular Dystrophies
Radiculopathy
Genetic Diseases, Inborn
Metabolic Diseases
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 30, 2014