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Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104921
Recruitment Status : Suspended (temporarily paused due to COVID-19 and expected to resume in the future; This is not a suspension of IRB approval)
First Posted : April 7, 2014
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Seward Rutkove, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease
Amyotrophic Lateral Sclerosis Muscular Dystrophy Radiculopathy Myopathy Polyneuropathy and Mononeuropathies Trauma Injury Orthopedic Disorder

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : December 2013
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Neuromuscular Disease Patients
Amyotrophic lateral sclerosis patients, myopathy patients, muscular dystrophy patients, myasthenia gravis patients, radiculopathy patients, mononeuropathy patients
Healthy volunteers


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT02104921


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
More Information
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Responsible Party: Seward Rutkove, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02104921    
Other Study ID Numbers: 2012P000364
2K24NS060951 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Muscular Dystrophies
Musculoskeletal Diseases
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Radiculopathy
Polyneuropathies
Mononeuropathies
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases