Clinical trial NCT02974530: Description and Modeling of Swallowing Disorders After a Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Swallowing Disorders
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
name: University Hospital, Caen
name: University Hospital, Montpellier
name: Centre Hospitalier du Pays d'Aix
name: Université Joseph Fourier
First posted: 2016-11-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Clinical severity score
timeFrame: At inclusion and 6 months after diagnosis
measure: Change of swallowing disorder
timeFrame: Within 15 days after diagnosis and 6 months after diagnosis
Secondary outcomes:
measure: Change of aphasia disorder
timeFrame: Within 15 days after diagnosis and 6 months after diagnosis
measure: Change of state of depression and anxiety
timeFrame: Within 15 days after diagnosis and 6 months after diagnosis
measure: Change of behavioural attention
timeFrame: Within 15 days after diagnosis and 6 months after diagnosis
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Hospital
city: Caen
country: France
facility: University hospital
city: Grenoble
country: France
facility: University hospital
city: Montpellier
country: France
facility: University hospital
Study officials:
References: