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Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)

This study is currently recruiting participants.

See

Contacts and Locations

Verified March 2017 by Seward Rutkove, Beth Israel Deaconess Medical Center

Sponsor:

ClinicalTrials.gov Identifier:

NCT02104921

First Posted: April 7, 2014

Last Update Posted: March 14, 2017

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.

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Seward Rutkove, Beth Israel Deaconess Medical Center

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: Neuromuscular Disorders

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis Muscular Dystrophy

U.S. FDA Resources

Further study details as provided by Seward Rutkove, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

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


Estimated Enrollment:	240
Study Start Date:	December 2013
Estimated Study Completion Date:	July 2019
Estimated Primary Completion Date:	July 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	21 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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 Institute of Neurological Disorders and Stroke (NINDS)

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:	2012P000364 2K24NS060951 ( U.S. NIH Grant/Contract )
First Submitted:	March 31, 2014
First Posted:	April 7, 2014
Last Update Posted:	March 14, 2017
Last Verified:	March 2017

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

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