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Description and Modeling of Swallowing Disorders After a Stroke

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02974530
Acronym
AVC-MODE
Enrollment
150
Registered
2016-11-28
Start date
2016-08-31
Completion date
2019-02-28
Last updated
2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Swallowing Disorders

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.

Interventions

OTHERLaryngological evaluation
OTHERBreathing investigation
OTHERMRI and articulatory investigation
OTHERPostural investigation
OTHERVoice and soundscape investigation

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change of Clinical severity scoreAt inclusion and 6 months after diagnosisNIHSS scale
Change of swallowing disorderWithin 15 days after diagnosis and 6 months after diagnosisTest : GUgging Swallowing Screen

Secondary

MeasureTime frameDescription
Change of aphasia disorderWithin 15 days after diagnosis and 6 months after diagnosisQuestionnaire : Aphasia rapid test
Change of behavioural attentionWithin 15 days after diagnosis and 6 months after diagnosisQuestionnaire : Catherine Bergego scale
Change of state of depression and anxietyWithin 15 days after diagnosis and 6 months after diagnosisQuestionnaire : anxiety and depression scale

Countries

France

Contacts

Primary ContactMarc Hommel, MD
mhommel@ujf-grenoble.fr
Backup ContactPhilippe Cousin
philippe.cousin@agim.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026