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Trial record 4 of 4 for:
"Fasciculation"
Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS) (ALS)
This study has been completed.
Sponsor:
Universidad Católica San Antonio de Murcia
Information provided by (Responsible Party):
Jacinto Martínez-Payá, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier:
NCT02507713
First received: July 20, 2015
Last updated: July 23, 2015
Last verified: July 2015
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Purpose
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.
- To establish the diagnostic value of ultrasonography in ALS.
- To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with ALS.
- 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.
| Condition |
|---|
| Amyotrophic Lateral Sclerosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis |
Resource links provided by NLM:
Further study details as provided by Jacinto Martínez-Payá, Universidad Católica San Antonio de Murcia:
Primary Outcome Measures:
- 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 Outcome Measures:
- Measurement muscle strength. [ Time Frame: 6 months ]Graded on the medical research council scale
- Measurement ALS Functional Rating Scale (ALSFRS-r) scale. [ Time Frame: 6 months ]Recorded as the global score
- Measurement muscle fasciculations. [ Time Frame: 6 months ]Each muscle will be screened during 10 s.
- Measuring muscle echointensity. [ Time Frame: 6 months ]It will be measured using the Image J (v.1.48) software in the biceps brachialis, forearm flexors, quadriceps and tibialis anterior, which will be compared between patient with ALS and control group.
- Measuring nerve area. [ Time Frame: 6 months ]This measurement is carried out in the median and tibialis posterior nerves, which will be compared between patient with ALS and control group.
| Enrollment: | 60 |
| Study Start Date: | September 2013 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patient with Amyotrophic Lateral Sclerosis.
Criteria
Inclusion Criteria:
- Definite ALS.
Exclusion Criteria:
- Primary Lateral Sclerosis (PLS)
- Other forms of motor neuron disorders.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02507713
Please refer to this study by its ClinicalTrials.gov identifier: NCT02507713
Locations
| Spain | |
| Universidad Católica San Antonio de Murcia | |
| Guadalupe, Murcia, Spain, 30107 | |
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
| Principal Investigator: | María E del Baño-Aledo, PhD | Human Anatomy Department. Universidad Católica San Antonio, Campus de los Jerónimos 138. 30107 Guadalupe, Murcia, Spain |
More Information
Publications:
| Responsible Party: | Jacinto Martínez-Payá, Professor of Human Anatomy and Biomedical Imaging, Universidad Católica San Antonio de Murcia |
| ClinicalTrials.gov Identifier: | NCT02507713 History of Changes |
| Other Study ID Numbers: |
PMAFI10/14 |
| Study First Received: | July 20, 2015 |
| Last Updated: | July 23, 2015 |
Keywords provided by Jacinto Martínez-Payá, Universidad Católica San Antonio de Murcia:
|
Amyotrophic lateral sclerosis Ultrasonography Motor neurons Neuromuscular diseases Fasciculation |
Additional relevant MeSH terms:
|
Sclerosis Motor Neuron Disease Amyotrophic Lateral Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on July 13, 2017