Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis; Muscular Dystrophy; Radiculopathy; Trauma Injury; Orthopedic Disorder; Myopathy; Polyneuropathy and Mononeuropathies

• Study Type: Observational
• Enrollment (Actual): 223

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Muscular Disorders, Atrophic; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Radiculopathy; Polyneuropathies; Musculoskeletal Diseases; Mononeuropathies
• Other Study ID Numbers: 2012P000364; 2K24NS060951 (U.S. NIH Grant/Contract)