Description and Modeling of Swallowing Disorders After a Stroke

NCT02974530 | Unknown

• 1 other identifier: 2016-A00070-51
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke; Swallowing Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change of aphasia disorder

  Within 15 days after diagnosis and 6 months after diagnosis

• Change of state of depression and anxiety

  Within 15 days after diagnosis and 6 months after diagnosis

• Change of behavioural attention

  Within 15 days after diagnosis and 6 months after diagnosis

Study Arms (2)

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: MRI and articulatory investigation; Other: Postural investigation; Other: Voice and soundscape investigation

Interventions

Neurological evaluation OTHER

Stroke population

Laryngological evaluation OTHER

Stroke population

MRI evaluation OTHER

Stroke population

Breathing investigation OTHER

Healthy population; Stroke population

MRI and articulatory investigation OTHER

Healthy population

Postural investigation OTHER

Healthy population; Stroke population

Voice and soundscape investigation OTHER

Healthy population; Stroke population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (4)

Hospital

Aix-en-Provence, France

NOT YET RECRUITING

University hospital

Caen, France

RECRUITING

University hospital

Grenoble, France

RECRUITING

University hospital

Montpellier, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Interventions

Magnetic Resonance Spectroscopy; Voice

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Marc Hommel, MD

CONTACT

mhommel@ujf-grenoble.fr

Philippe Cousin

CONTACT

philippe.cousin@agim.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: November 28, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2019
• Last Updated: July 17, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)