Neuromuscular Ultrasound in ALS

Completed

• Conditions: ALS
• Interventions: Other: Ultrasound of nerve and muscle

• Registration Number: NCT01785550
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects referred to the electromyography laboratory for ALS.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound Group	Ultrasound of nerve and muscle	All will receive nerve and muscle ultrasound.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States