Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: medical device

Study type: Interventional

Funder types: Other

Identifiers

NCT02665663

2015-18

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

healthy volunteers

Other group

Description:

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

Treatment:

Device: medical device

Patients with Amyotrophic Lateral Sclerosis

Other group

Description:

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.

Treatment:

Device: medical device

patients with Amyotrophic Lateral Sclerosis and swallowi

Other group

Description:

Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation.

Treatment:

Device: medical device