Neuromuscular Ultrasound in ALS
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|ClinicalTrials.gov Identifier: NCT01785550|
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : March 11, 2015
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Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease affecting motor neurons. Early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. Nerve and muscle ultrasound may provide this information.
This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in ALS.
|Condition or disease||Intervention/treatment|
|ALS||Other: Ultrasound of nerve and muscle|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Ultrasonography in Amyotrophic Lateral Sclerosis as a Predictor of Disease Progression and Tool in Diagnosis: a Pilot Study|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
No intervention to be performed.
All will receive nerve and muscle ultrasound.
Other: Ultrasound of nerve and muscle
Ultrasound of 6 muscles and 2 nerves will be performed.
- Abnormalities at onset: Ultrasound vs. Electromyography [ Time Frame: 1 year ]Ultrasound measures will be compared to electromyography measures at the patient's initial assessment. The number of abnormal muscles will be counted using each technique and analyzed to determine if one test is superior.
- Ultrasound Predicting Outcome at 1 year [ Time Frame: 1.5 years ]The initial ultrasound measures and patient outcomes, as measured by standard validated scales, will be assessed at periodic intervals for one year. Analysis will be performed to determine if ultrasound measures can predict the clinical course.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Subjects referred to the electromyography laboratory for ALS.
- Patients with known comorbid myopathy or neuropathy will be excluded from the study.
- Patients unable to provide their own consent will be excluded.
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): NCT01785550
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
|First Posted:||February 7, 2013 Key Record Dates|
|Last Update Posted:||March 11, 2015|
|Last Verified:||March 2015|