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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 : March 5, 2018
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

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 2018
Estimated Study Completion Date : July 2019

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Contacts
Contact: Hilda Gutierrez, MD 617-667-3053 hgutier1@bidmc.harvard.edu
Contact: Maria Martucci, MD 617-667-3053 mmartucc@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Maria Martucci    617-667-3015    mmartucc@bidmc.harvard.edu   
Principal Investigator: Seward B Rutkove, MD         
Sub-Investigator: Courtney McIlduff, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Seward Rutkove, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02104921     History of Changes
Other Study ID Numbers: 2012P000364
2K24NS060951 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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