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Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
medical device
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Service ORL Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

healthy volunteers

Patients with Amyotrophic Lateral Sclerosis

patients with Amyotrophic Lateral Sclerosis and swallowi

Arm 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

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.

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

Outcomes

Primary Outcome Measures

Maximum tongue strength
maximal tongue strength during salivary swallowing
Tongue contact duration
Duration of tongue and palate contact during salivary

Secondary Outcome Measures

Full Information

First Posted
January 25, 2016
Last Updated
January 27, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02665663
Brief Title
Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)
Official Title
Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
Other
Arm 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
Arm Title
Patients with Amyotrophic Lateral Sclerosis
Arm Type
Other
Arm 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.
Arm Title
patients with Amyotrophic Lateral Sclerosis and swallowi
Arm Type
Other
Arm Description
Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation.
Intervention Type
Device
Intervention Name(s)
medical device
Primary Outcome Measure Information:
Title
Maximum tongue strength
Description
maximal tongue strength during salivary swallowing
Time Frame
30 minutes
Title
Tongue contact duration
Description
Duration of tongue and palate contact during salivary
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aude LAGIER, MCU-PH
Phone
04 91 38 60 71
Email
aude.lagier@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Service ORL Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude LAGIER, MCU-PH
Phone
04 91 38 60 71
Email
aude.lagier@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Aude LAGIER, MCU-PH

12. IPD Sharing Statement

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Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)

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