Muscle Ultrasound: A New Tool for Measuring Progression in Amyotrophic Lateral Sclerosis (ALS) - Full Text View

Purpose

This is a study in patients with Amyotrophic Lateral Sclerosis (ALS). We will use muscle ultrasound as a tool to try and see if there are changes in muscle size that can find out how fast ALS is progressing. This might give us a better way to carry out further studies on new drugs to see if they might help slow the progression of ALS.

Participants in the study will have muscle ultrasound performed on a few muscles in the arms and legs at the first visit, and again 3 months later, and one last time 3 months after that. This takes about 10 minutes, is painless, and involves scanning the muscle with a handheld device, with some gel applied to the skin. At each visit, there will also be a questionnaire about symptoms and strength testing.

Condition
Amyotrophic Lateral Sclerosis

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Muscle Ultrasound: A New Tool for Measuring Progression in ALS

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Muscle thickness, as measured by muscle ultrasound, will decrease over time in patients with ALS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Muscle thickness, as measured by muscle ultrasound, will correlate with decline in strength testing. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Muscle thickness, as measured by muscle ultrasound, will correlate with decline in the ALS-FRS (ALS Functional Rating Scale) over time. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Muscle echogenicity, as measured by muscle ultrasound, will increase in time, and will correlate with loss of muscle strength. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	February 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Participants with ALS Participants diagnosed with ALS.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with ALS (Amyotrophic Lateral Sclerosis)

Criteria

Inclusion Criteria:

must meet the El Escorial criterion for definite or probable ALS.
forced vital capacity (FVC) must exceed 50%.

Exclusion Criteria:

Patients with primary lateral sclerosis (PLS) and other forms of motor neuron disorders
severe weakness from ALS who require continuous mechanical ventilation, who have a forced vital capacity less than 50%, or who have no clinically measurable strength in the arms and legs.
Patients without cognitive capacity to give informed consent. (This is not a clinical feature of ALS, and therefore such patients would have an alternate diagnosis that would prevent such capacity.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838617

Locations

United States, Tennessee
ALS Clinic, Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:	Christopher D Lee, MD	Vanderbilt University
Study Director:	Peter D Donofrio, MD	Vanderbilt University

More Information

Publications:

Walker FO. Neuromuscular ultrasound. Neurol Clin. 2004 Aug;22(3):563-90, vi. Review.

Arts IM, van Rooij FG, Overeem S, Pillen S, Janssen HM, Schelhaas HJ, Zwarts MJ. Quantitative muscle ultrasonography in amyotrophic lateral sclerosis. Ultrasound Med Biol. 2008 Mar;34(3):354-61. Epub 2007 Oct 26.

Unrath A, Ludolph AC, Kassubek J. Brain metabolites in definite amyotrophic lateral sclerosis. A longitudinal proton magnetic resonance spectroscopy study. J Neurol. 2007 Aug;254(8):1099-106. Epub 2007 Apr 13.

Pillen S, Arts IM, Zwarts MJ. Muscle ultrasound in neuromuscular disorders. Muscle Nerve. 2008 Jun;37(6):679-93. Review.

Arts IM, Pillen S, Overeem S, Schelhaas HJ, Zwarts MJ. Rise and fall of skeletal muscle size over the entire life span. J Am Geriatr Soc. 2007 Jul;55(7):1150-2. No abstract available.

Lacomblez L, Bensimon G, Leigh PN, Guillet P, Meininger V. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis/Riluzole Study Group II. Lancet. 1996 May 25;347(9013):1425-31.

Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. Review. No abstract available.

Responsible Party:	Christopher D. Lee, MD, Clinical Fellow, Department of Neurology, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00838617 History of Changes
Other Study ID Numbers:	081243
Study First Received:	February 4, 2009
Last Updated:	December 10, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Amyotrophic Lateral Sclerosis
Ultrasonography
Atrophy

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases

Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013