Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02665663
• Other study ID #: 2015-18
• Status: Not yet recruiting
• Phase: N/A
• First received: January 25, 2016
• Last updated: January 27, 2016
• Start date: February 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Aude LAGIER, MCU-PH
• Phone: 04 91 38 60 71
• Email: aude.lagier[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Device:
• medical device

Locations

Country	Name	City	State
France	Service ORL Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tongue strength	maximal tongue strength during salivary swallowing	30 minutes	No
Primary	Tongue contact duration	Duration of tongue and palate contact during salivary	30 minutes	No