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Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT02665663
Recruitment Status : Unknown
Verified January 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: medical device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders
Study Start Date : February 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
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
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
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



Primary Outcome Measures :
  1. Maximum tongue strength [ Time Frame: 30 minutes ]
    maximal tongue strength during salivary swallowing

  2. Tongue contact duration [ Time Frame: 30 minutes ]
    Duration of tongue and palate contact during salivary



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665663


Contacts
Contact: Aude LAGIER, MCU-PH 04 91 38 60 71 aude.lagier@ap-hm.fr

Locations
France
Service ORL Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13005
Contact: Aude LAGIER, MCU-PH    04 91 38 60 71    aude.lagier@ap-hm.fr   
Principal Investigator: Aude LAGIER, MCU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02665663     History of Changes
Other Study ID Numbers: 2015-18
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases