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Clinical Trials/NCT02507713
NCT02507713
Completed
Not Applicable

Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis

Universidad Católica San Antonio de Murcia1 site in 1 country60 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
60
Locations
1
Primary Endpoint
Measuring muscle thickness.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease. Nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the electrophysiologic study.

Objectives.

  1. To establish the diagnostic value of ultrasonography in ALS.
  2. To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with ALS.
  3. To check the relationship between ultrasound, clinical variables and functional tests in patients with ALS.

Methods. A longitudinal observational study in a consecutive sample of patients diagnosed with ALS will be realized. All the patients will be examined 3 times during 6 months and capabilities associated with ALS and muscle strength will be assessed. Bilateral and cross sectional ultrasonography of several muscles and also median and tibial nerves will be performed. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness and nerve area) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded. After longitudinal study, a survival study will be performed in relation to functional and sonographic variables.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
April 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

Jacinto Martínez-Payá

Professor of Human Anatomy and Biomedical Imaging

Universidad Católica San Antonio de Murcia

Eligibility Criteria

Inclusion Criteria

  • Definite ALS.

Exclusion Criteria

  • Primary Lateral Sclerosis (PLS)
  • Other forms of motor neuron disorders.

Outcomes

Primary Outcomes

Measuring muscle thickness.

Time Frame: 6 months

This measurement is carried out in the biceps brachialis, forearm flexors, quadriceps and tibialis anterior, which will be compared between patient with ALS and control group.

Secondary Outcomes

  • Measurement ALS Functional Rating Scale (ALSFRS-r) scale.(6 months)
  • Measurement muscle fasciculations.(6 months)
  • Measurement muscle strength.(6 months)
  • Measuring muscle echointensity.(6 months)
  • Measuring nerve area.(6 months)

Study Sites (1)

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