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Clinical Trials/NCT01785550
NCT01785550
Completed
Not Applicable

Ultrasonography in Amyotrophic Lateral Sclerosis as a Predictor of Disease Progression and Tool in Diagnosis: a Pilot Study

Duke University1 site in 1 country40 target enrollmentFebruary 2013
ConditionsALS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ALS
Sponsor
Duke University
Enrollment
40
Locations
1
Primary Endpoint
Abnormalities at onset: Ultrasound vs. Electromyography
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
March 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Ultrasound Predicting Outcome at 1 year(1.5 years)

Study Sites (1)

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