Study Purpose:
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.
1. To evaluate the evolution of diaphragmatic and peripheral neuromuscular degeneration by ultrasound examination in patients with ALS and to establish possible evolution patterns.
2. To verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used.
3. 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.
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational [Patient Registry]
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Antonio Tomás Ríos Cortés, HOSPITAL GENERAL UNIVERSITARIO SANTA LUCIA - SERVICIO MURCIANO DE SALUD
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Hospital General Universitario Santa Lucia
Estimated Enrollment:
26
Estimated Study Start Date:
10 / 01 / 2018
Estimated Study Completion Date:
03 / 10 / 2020
Posting Last Modified Date:
11 / 05 / 2021
Date Study Added to neals.org:
09 / 25 / 2018
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:- Definite ALS
Exclusion Criteria:
- Primary Lateral Sclerosis (PLS)
- Other forms of motor neuron disorders
Hospital General Universitario Santa Lucia
Cartagena, Murcia
30202
Spain