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

This study has been completed.
Information provided by:
Vanderbilt University Identifier:
First received: February 4, 2009
Last updated: December 10, 2009
Last verified: December 2009

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.

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:

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)
Participants with ALS
Participants diagnosed with ALS.

  Show Detailed Description


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)


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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00838617

United States, Tennessee
ALS Clinic, Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Christopher D Lee, MD Vanderbilt University
Study Director: Peter D Donofrio, MD Vanderbilt University
  More Information

Responsible Party: Christopher D. Lee, MD, Clinical Fellow, Department of Neurology, Vanderbilt University 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

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies processed this record on November 20, 2014