Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by Beth Israel Deaconess Medical Center
Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Seward Rutkove, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT02104921
First received: March 31, 2014
Last updated: July 19, 2016
Last verified: July 2016
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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:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
Muscular Dystrophy
Neuromuscular Disorders
Genetic and Rare Diseases Information Center resources:
Muscular Dystrophy
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
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 (Adult, Senior) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02104921
Contacts
| Contact: Carmen Shin | 617-667-3053 | cshin1@bidmc.harvard.edu | |
| Contact: Maria Martucci | 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 syim1@bidmc.harvard.edu | |
| Principal Investigator: Seward B Rutkove, MD | |
| Sub-Investigator: Courtney McIlduff, MD | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
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: | 2K24NS060951 |
| Study First Received: | March 31, 2014 |
| Last Updated: | July 19, 2016 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 23, 2016