Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

Study Overview
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Brief Summary
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Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants. Swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. The issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy. The objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.

Official Title
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Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: medical device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults and legally responsible/ valid medical insurance patients : ALS diagnostic already announced healthy subjects : EAT-10 score<2 Exclusion Criteria: Non pregnant and non baby feeding Presence of risk factor or suspicion of Creutzfeld Jacob Disease Allergy/intolerance to the glueing paste Antecedent of pathology of the aerodigestive tract Other neurologic disease Morphologic anomaly of the aerodigestive tract Excessive gag reflex

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: healthy volunteers<br>Constitution of a control group consisting of 20 healthy volunteers, matched for age and sex to establish a normal pressure force of the language depending on the age and sex value | Device: medical device<br> <br> |
| Other: Patients with Amyotrophic Lateral Sclerosis<br>Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis (ALS), included at diagnosis of the disease on clinical and electromyographic arguments addressed in speech pathology consultation without a complaint swallowing. | Device: medical device<br> <br> |
| Other: patients with Amyotrophic Lateral Sclerosis and swallowi<br>Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation. | Device: medical device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tongue strength | maximal tongue strength during salivary swallowing | 30 minutes | 
| Tongue contact duration | Duration of tongue and palate contact during salivary | 30 minutes |