Neuromuscular Ultrasound in ALS

ALS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785550
• Other study ID #: Pro00042025
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: March 10, 2015
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis

Intervention

Other:
• Ultrasound of nerve and muscle
Ultrasound of 6 muscles and 2 nerves will be performed.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormalities at onset: Ultrasound vs. Electromyography	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.	1 year	No
Secondary	Ultrasound Predicting Outcome at 1 year	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.	1.5 years	No