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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2016 |
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Main ID: |
NCT02665663 |
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Date of registration:
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25/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02665663 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Aude LAGIER, MCU-PH |
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Address:
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Telephone:
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04 91 38 60 71 |
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Email:
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aude.lagier@ap-hm.fr |
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Affiliation:
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Name:
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Aude LAGIER, MCU-PH |
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Address:
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Telephone:
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04 91 38 60 71 |
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Email:
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aude.lagier@ap-hm.fr |
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Affiliation:
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Name:
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Urielle DESALBRES |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique Hôpitaux de Marseille |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Device: medical device
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Primary Outcome(s)
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Tongue contact duration
[Time Frame: 30 minutes]
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Maximum tongue strength
[Time Frame: 30 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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