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Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)

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ClinicalTrials.gov Identifier: NCT02104921
Recruitment Status : Recruiting
First Posted : April 7, 2014
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Seward Rutkove, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date March 31, 2014
First Posted Date April 7, 2014
Last Update Posted Date August 28, 2019
Study Start Date December 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2014)
Quantitative ultrasound data, including quantified grayscale data and backscattered acoustic data [ Time Frame: 1 year ]
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02104921 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Innovative Ultrasound Technology in Neuromuscular Disease
Official Title Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Amyotrophic Lateral Sclerosis
  • Muscular Dystrophy
  • Radiculopathy
  • Myopathy
  • Polyneuropathy and Mononeuropathies
  • Trauma Injury
  • Orthopedic Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Neuromuscular Disease Patients
    Amyotrophic lateral sclerosis patients, myopathy patients, muscular dystrophy patients, myasthenia gravis patients, radiculopathy patients, mononeuropathy patients
  • Healthy volunteers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 2, 2014)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hilda Gutierrez, MD 617-667-3053 hgutier1@bidmc.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02104921
Other Study ID Numbers 2012P000364
2K24NS060951 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Seward Rutkove, Beth Israel Deaconess Medical Center
Study Sponsor Beth Israel Deaconess Medical Center
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date August 2019