Description and Modeling of Swallowing Disorders After a Stroke

NCT ID: NCT02974530

Last Updated: 2017-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Swallowing Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stroke population

Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.

Neurological evaluation

Intervention Type OTHER

Laryngological evaluation

Intervention Type OTHER

MRI evaluation

Intervention Type OTHER

Breathing investigation

Intervention Type OTHER

Postural investigation

Intervention Type OTHER

Voice and soundscape investigation

Intervention Type OTHER

Healthy population

Healthy subjects will be explored in Grenoble in research laboratory

Breathing investigation

Intervention Type OTHER

MRI and articulatory investigation

Intervention Type OTHER

Postural investigation

Intervention Type OTHER

Voice and soundscape investigation

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurological evaluation

Intervention Type OTHER

Laryngological evaluation

Intervention Type OTHER

MRI evaluation

Intervention Type OTHER

Breathing investigation

Intervention Type OTHER

MRI and articulatory investigation

Intervention Type OTHER

Postural investigation

Intervention Type OTHER

Voice and soundscape investigation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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

* 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


* MRI contraindication
* Pregnant, parturient or nursing woman
* Simultaneous participation in another study
* Non registered to the French social security system
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Agency, France

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Centre Hospitalier du Pays d'Aix

OTHER

Sponsor Role collaborator

Université Joseph Fourier

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital

Aix-en-Provence, , France

Site Status NOT_YET_RECRUITING

University hospital

Caen, , France

Site Status RECRUITING

University hospital

Grenoble, , France

Site Status RECRUITING

University hospital

Montpellier, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marc Hommel, MD

Role: CONTACT

Philippe Cousin

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A00070-51

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cough and Swallow Rehab Following Stroke
NCT01907321 COMPLETED PHASE1/PHASE2