Innovative Ultrasound Technology in Neuromuscular Disease

NCT02104921 | Completed

• 2 other identifiers: 2012P0003642K24NS060951
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Muscular Dystrophy; Radiculopathy; Myopathy; Polyneuropathy and Mononeuropathies; Trauma Injury; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Neuromuscular Disease Patients

Amyotrophic lateral sclerosis patients, myopathy patients, muscular dystrophy patients, myasthenia gravis patients, radiculopathy patients, mononeuropathy patients

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.

You may not qualify if:

• Multiple generalized neuromuscular conditions.

Sponsors & Collaborators

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

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Radiculopathy; Muscular Diseases; Polyneuropathies; Mononeuropathies; Accidental Injuries; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Disorders, Atrophic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 7, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

US (1)