Description and Modeling of Swallowing Disorders After a Stroke (AVC-MODE)

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Swallowing Disorders
• Intervention / Treatment: Other: Neurological evaluation; Other: Laryngological evaluation; Other: MRI evaluation; Other: Breathing investigation; Other: Postural investigation; Other: Voice and soundscape investigation; Other: MRI and articulatory investigation

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Marc Hommel, MD; Email: mhommel@ujf-grenoble.fr
• Study Contact Backup: Name: Philippe Cousin; Email: philippe.cousin@agim.eu

Study Locations

• France
  • Aix en Provence, France
    • Not yet recruiting
    • Hospital
    • Principal Investigator: Dominique Gayraud, MD
  • Caen, France
    • Recruiting
    • University Hospital
    • Principal Investigator: Emmanuel Touze, MD
  • Grenoble, France
    • Recruiting
    • University Hospital
    • Principal Investigator: Olivier Detante, MD
  • Montpellier, France
    • Not yet recruiting
    • University Hospital
    • Principal Investigator: Nicolas Menjot de Champfleur, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multicenter study with two cohorts unpaired : first of healthy subjects / second of patient with ischemic stroke.

Study size expected :

• 120 stroke patients in 4 University Hospital
• 30 healthy subjects explored in research laboratory

Description

For patients after stroke

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Montpellier; University Hospital, Caen; National Research Agency, France; Université Joseph Fourier; Centre Hospitalier du Pays d'Aix

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2016-A00070-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO