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NCT02104921 Clinical Trial

Innovative Ultrasound Technology in Neuromuscular Disease

Amyotrophic Lateral Sclerosis Clinical Trial

— AQUIRe  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02104921
Other study ID # 2012P000364
Secondary ID 2K24NS060951
Status Completed
Phase
First received
Last updated
Start date December 1, 2013
Est. completion date March 1, 2020

Study information
Verified date March 2022
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 223
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantitative ultrasound data, including quantified grayscale data and backscattered acoustic data 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 1 year
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