Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

NCT02665663 | Unknown

• 1 other identifier: 2015-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (2)

• Maximum tongue strength

  maximal tongue strength during salivary swallowing

  30 minutes

• Tongue contact duration

  Duration of tongue and palate contact during salivary

  30 minutes

Study Arms (3)

healthy volunteers

OTHER

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

Patients with Amyotrophic Lateral Sclerosis

OTHER

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

patients with Amyotrophic Lateral Sclerosis and swallowi

OTHER

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

Device: medical device

Interventions

medical device DEVICE

Patients with Amyotrophic Lateral Sclerosis; healthy volunteers; patients with Amyotrophic Lateral Sclerosis and swallowi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults and legally responsible/ valid medical insurance
• patients : ALS diagnostic already announced
• healthy subjects : EAT-10 score\<2

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service ORL Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Aude LAGIER, MCU-PH

CONTACT

04 91 38 60 71; aude.lagier@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

FR (1)