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
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|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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|
Participants with ALS
Participants diagnosed with ALS.
- Muscle thickness, as measured by muscle ultrasound, will decrease over time in patients with ALS. [ Time Frame: 6 months ]
- Muscle thickness, as measured by muscle ultrasound, will correlate with decline in strength testing. [ Time Frame: 6 months ]
- 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 ]
- Muscle echogenicity, as measured by muscle ultrasound, will increase in time, and will correlate with loss of muscle strength. [ Time Frame: 6 months ]
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
|United States, Tennessee|
|ALS Clinic, Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Christopher D Lee, MD||Vanderbilt University Medical Center|
|Study Director:||Peter D Donofrio, MD||Vanderbilt University Medical Center|