Neuromuscular Ultrasound in ALS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ALS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound of nerve and muscle

Other

Ultrasound of 6 muscles and 2 nerves will be performed.

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

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Feb 7, 2013
Registry last updated: Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed