Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Device: medical device

• Registration Number: NCT02665663
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Study Start: 2016-02
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	medical device	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
Patients with Amyotrophic Lateral Sclerosis	medical device	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.
patients with Amyotrophic Lateral Sclerosis and swallowi	medical device	Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation.

Primary Outcome Measures

Name	Time	Method
Maximum tongue strength	30 minutes	maximal tongue strength during salivary swallowing
Tongue contact duration	30 minutes	Duration of tongue and palate contact during salivary

Trial Locations

Locations (1)

Service ORL Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France