Description and Modeling of Swallowing Disorders After a Stroke

• Conditions: Stroke; Swallowing Disorders

• Registration Number: NCT02974530
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing, Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered, isolated or associated manner, causing major disorders and representing a source of handicap for patients.

Understanding the swallowing mechanisms is therefore a major challenge to guide the rehabilitation and improve the initial and long-term prognosis of patients with stroke.

The main objective of this study is to describe and modeling, thanks to a clinical, physiological and radiological knowledge base, swallowing, speech and breathing, in patients with stroke and in healthy subjects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-17
• Primary Completion: 2018-08
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• First stroke confirmed by MRI < 15 days
• No severe leukoaraiosis
• Swallowing disorders identified (GUSS scale < 20)
• Neurological deficit identified (NIHSS scale <15)
• Patient able to cooperate for investigations
• Informed consent signed

Exclusion Criteria

• Cerebral hemorrhage
• History of neurological disease that can lead to swallowing disorders
• History of laryngological disease such as previous surgery or radiation neck
• Tracheotomy
• Vigilance disorders
• Pregnant, parturient or nursing woman
• Protected adult
• Simultaneous participation in another study
• Non registered to the French social security system

For healthy subjects

Inclusion Criteria :

• Age between 18 and 40 years old
• French native speaker
• Normal hearing with or without corrective
• No oral or written language disorders
• No neurological or psychiatric disorders
• Informed consent signed

Exclusion Criteria

• MRI contraindication
• Pregnant, parturient or nursing woman
• Simultaneous participation in another study
• Non registered to the French social security system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Clinical severity score	At inclusion and 6 months after diagnosis	NIHSS scale
Change of swallowing disorder	Within 15 days after diagnosis and 6 months after diagnosis	Test : GUgging Swallowing Screen

Secondary Outcome Measures

Name	Time	Method
Change of aphasia disorder	Within 15 days after diagnosis and 6 months after diagnosis	Questionnaire : Aphasia rapid test
Change of behavioural attention	Within 15 days after diagnosis and 6 months after diagnosis	Questionnaire : Catherine Bergego scale
Change of state of depression and anxiety	Within 15 days after diagnosis and 6 months after diagnosis	Questionnaire : anxiety and depression scale

Trial Locations

Locations (2)

Hospital; 🇫🇷 Aix en Provence, France

University hospital; 🇫🇷 Montpellier, France