Ultrasonography of the Neuromuscular Degeneration Behavior in ALS: a Longitudinal Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- Hospital General Universitario Santa Lucia
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Measuring echointensity of peripheral muscles using an ultrasound device
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.
An exhaustive and frequent clinical evaluation can lead to establish an adequate and early treatment of the consequences of its evolution.
Objectives.
- To evaluate the evolution of diaphragmatic and peripheral neuromuscular degeneration by ultrasound examination in patients with ALS and to establish possible evolution patterns.
- To verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used.
- To compare the ultrasonographic features of subjects with ALS and a sample of healthy subjects 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, with an interval of at least 3 months between tests. Bilateral and cross sectional ultrasonography of several peripheral muscles and diaphragm will be performed at rest and during muscle contraction. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded in peripheral muscles.Also clinical features will be noted, every time of the 3 exams, from Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r), British Medical Council Research Scale(MRC), and routine pulmonary tests.
Investigators
Antonio Tomás Ríos-Cortés
Msc Physiotherapist
Hospital General Universitario Santa Lucia
Eligibility Criteria
Inclusion Criteria
- •Definite ALS
Exclusion Criteria
- •Primary Lateral Sclerosis (PLS)
- •Other forms of motor neuron disorders
Outcomes
Primary Outcomes
Measuring echointensity of peripheral muscles using an ultrasound device
Time Frame: 3 months
These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.
Thickness Fraction of the Diaphragm in ALS patients and control group.
Time Frame: 3 months
It is calculated as the difference between thickness at end inspiration and end expiration
Measuring thickness of peripheral muscles using an ultrasound device
Time Frame: 3 months
These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.
Measuring sonoelastography of peripheral muscles using an ultrasound device
Time Frame: 3 months
These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.
Diaphragmatic Excursion (quiet and forced) of the Diaphragm in ALS patients and control group
Time Frame: 3 months
Displacement of the right diaphragm dome
Secondary Outcomes
- Measurement of muscle fasciculations using an ultrasound device(3 months)
- Measurement of muscle strength using Medical Research Council Scale (MRCs)(3 months)
- Measurement Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r)(3 months)
- Maximal Inspiratory Pressure (MIP)(3 months)
- Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)(3 months)
- Measuring Forced Vital Capacity(3 months)
- Sniff- nasal inspiratory pressure (SNIP)(3 months)
- Peak Cough Flow (PCF)(3 months)
- Cumulative time percentage with SpO2 under 90% (CT90)(3 months)