Description and Modeling of Swallowing Disorders After a Stroke

• Conditions: Stroke; Swallowing Disorders
• Interventions: Other: Neurological evaluation; Other: Laryngological evaluation; Other: MRI and articulatory investigation; Other: MRI evaluation; Other: Postural investigation; Other: Breathing investigation; Other: Voice and soundscape investigation

• 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

Arm && Interventions

Group	Intervention	Description
Stroke population	Neurological evaluation	Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
Stroke population	MRI evaluation	Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
Stroke population	Breathing investigation	Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
Stroke population	Voice and soundscape investigation	Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
Healthy population	Postural investigation	Healthy subjects will be explored in Grenoble in research laboratory
Stroke population	Postural investigation	Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
Healthy population	Voice and soundscape investigation	Healthy subjects will be explored in Grenoble in research laboratory
Stroke population	Laryngological evaluation	Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
Healthy population	Breathing investigation	Healthy subjects will be explored in Grenoble in research laboratory
Healthy population	MRI and articulatory investigation	Healthy subjects will be explored in Grenoble in research laboratory

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