Description and Modeling of Swallowing Disorders After a Stroke

Stroke Clinical Trial

— AVC-MODE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974530
• Other study ID #: 2016-A00070-51
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2016
• Last updated: July 12, 2017
• Start date: August 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2016
• Source: University Hospital, Grenoble
• Contact: Marc Hommel, MD
• Email: mhommel[@]ujf-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Stroke
• Swallowing Disorders

Intervention

Other:
• Neurological evaluation

• Laryngological evaluation

• MRI evaluation

• Breathing investigation

• MRI and articulatory investigation

• Postural investigation

• Voice and soundscape investigation

Locations

Country	Name	City	State
France	Hospital	Aix en Provence
France	University hospital	Caen
France	University hospital	Grenoble
France	University hospital	Montpellier

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Centre Hospitalier du Pays d'Aix, National Research Agency, France, Université Joseph Fourier, University Hospital, Caen, University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Clinical severity score	NIHSS scale	At inclusion and 6 months after diagnosis
Primary	Change of swallowing disorder	Test : GUgging Swallowing Screen	Within 15 days after diagnosis and 6 months after diagnosis
Secondary	Change of aphasia disorder	Questionnaire : Aphasia rapid test	Within 15 days after diagnosis and 6 months after diagnosis
Secondary	Change of state of depression and anxiety	Questionnaire : anxiety and depression scale	Within 15 days after diagnosis and 6 months after diagnosis
Secondary	Change of behavioural attention	Questionnaire : Catherine Bergego scale	Within 15 days after diagnosis and 6 months after diagnosis