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

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00838617

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

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Ultrasound

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 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	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Christopher D Lee, MD 615-936-0060 christopher.lee@vanderbilt.edu
Contact: Peter D Donofrio, MD 615-936-0060 peter.donofrio@vanderbilt.edu
Principal Investigator: Christopher D Lee, MD
Sub-Investigator: Amanda C Peltier, MD
Sub-Investigator: Peter D Donofrio, MD
Sub-Investigator: Adrian Jarquin-Valdivia, MD

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:	Department of Neurology, Vanderbilt University ( Christopher D. Lee, MD, Clinical Fellow )
Study ID Numbers:	081243
Study First Received:	February 4, 2009
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00838617 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Amyotrophic Lateral Sclerosis
Ultrasonography
Atrophy

Study placed in the following topic categories:

Lou Gehrig's Disease
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Disease Progression
Central Nervous System Diseases

Atrophy
Sclerosis
Neurodegenerative Diseases
Degenerative Motor System Disease
Motor Neuron Disease

Additional relevant MeSH terms:

Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases

Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on May 06, 2009