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Trial record 96 of 488 for:    ALS (Amyotrophic Lateral Sclerosis)

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

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ClinicalTrials.gov Identifier: NCT00838617
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : December 11, 2009
Sponsor:
Information provided by:
Vanderbilt University

Brief Summary:

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 or disease
Amyotrophic Lateral Sclerosis

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Muscle Ultrasound: A New Tool for Measuring Progression in ALS
Study Start Date : February 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009


Group/Cohort
Participants with ALS
Participants diagnosed with ALS.



Primary Outcome Measures :
  1. Muscle thickness, as measured by muscle ultrasound, will decrease over time in patients with ALS. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Muscle thickness, as measured by muscle ultrasound, will correlate with decline in strength testing. [ Time Frame: 6 months ]
  2. 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 ]
  3. Muscle echogenicity, as measured by muscle ultrasound, will increase in time, and will correlate with loss of muscle strength. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.)

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): NCT00838617


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

Publications:
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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
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009

Keywords provided by Vanderbilt University:
Amyotrophic Lateral Sclerosis
Ultrasonography
Atrophy

Additional relevant MeSH terms:
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Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases