Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02104921 |
Recruitment Status
:
Recruiting
First Posted
: April 7, 2014
Last Update Posted
: March 5, 2018
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Condition or disease |
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Amyotrophic Lateral Sclerosis Muscular Dystrophy Radiculopathy Myopathy Polyneuropathy and Mononeuropathies |
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 |

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

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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 |
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.

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