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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Stroke
Swallowing Disorders

Treatments

Other: Breathing investigation
Other: Postural investigation
Other: MRI and articulatory investigation
Other: Laryngological evaluation
Other: Voice and soundscape investigation
Other: Neurological evaluation
Other: MRI evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT02974530
2016-A00070-51

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

150 participants in 2 patient groups

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

Trial contacts and locations

4

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Central trial contact

Philippe Cousin; Marc Hommel, MD

Data sourced from clinicaltrials.gov

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