Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

January 27, 2016 updated by: Assistance Publique Hopitaux De Marseille

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13005
        • Service ORL Assistance Publique Hôpitaux de Marseille
        • Contact:
        • Principal Investigator:
          • Aude LAGIER, MCU-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: healthy volunteers
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
Other: Patients with Amyotrophic Lateral Sclerosis
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
Other: patients with Amyotrophic Lateral Sclerosis and swallowi
Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation.
Device: medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tongue strength
Time Frame: 30 minutes
maximal tongue strength during salivary swallowing
30 minutes
Tongue contact duration
Time Frame: 30 minutes
Duration of tongue and palate contact during salivary
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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