ALS
Conditions
Brief summary
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.
Interventions
OTHERUltrasound of nerve and muscle
Ultrasound of 6 muscles and 2 nerves will be performed.
Sponsors
Duke University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects referred to the electromyography laboratory for ALS.
Exclusion criteria
* Patients with known comorbid myopathy or neuropathy will be excluded from the study. * Patients unable to provide their own consent will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormalities at onset: Ultrasound vs. Electromyography | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Predicting Outcome at 1 year | 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. |
Countries
United States
Outcome results
None listed