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Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665663
Enrollment
60
Registered
2016-01-28
Start date
2016-02-29
Completion date
2018-07-31
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

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.

Interventions

DEVICEmedical device

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum tongue strength30 minutesmaximal tongue strength during salivary swallowing
Tongue contact duration30 minutesDuration of tongue and palate contact during salivary

Countries

France

Contacts

Primary ContactAude LAGIER, MCU-PH
aude.lagier@ap-hm.fr04 91 38 60 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026