StrokeAVC-MODENCT02974530
Description and Modeling of Swallowing Disorders After a Stroke
An observational study of Stroke and Swallowing Disorders, run by University Hospital, Grenoble at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Swallowing Disorders
- What is being tested?
- Neurological evaluation, Laryngological evaluation and MRI evaluation
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- Aug 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Marc Hommel, MD contact
Philippe Cousin contact
France4 sites, 4 recruiting
- Not yet recruiting
Hospital
Aix-en-Provence
Dominique Gayraud, MD
- Recruiting
University hospital
Caen
Emmanuel Touze, MD
- Recruiting
University hospital
Grenoble
Olivier Detante, MD
- Not yet recruiting
University hospital
Montpellier
Nicolas Menjot de Champfleur, MD
About this study
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
- Being tested
- Neurological evaluation, Laryngological evaluation, MRI evaluation, Breathing investigation, MRI and articulatory investigation
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological evaluationOther
Laryngological evaluationOther
MRI evaluationOther
Breathing investigationOther
MRI and articulatory investigationOther
Postural investigationOther
Voice and soundscape investigationOther
| Study group | Role | What they receive |
|---|---|---|
| Stroke population | Patient with stroke will be explored during their acute phase and in 6 months of diagnosis. Receives: 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 Receives: Other: Breathing investigation; Other: MRI and articulatory investigation; Other: Postural investigation; Other: Voice and soundscape investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Clinical severity score
NIHSS scale
Measured: At inclusion and 6 months after diagnosis
Change of swallowing disorder
Test : GUgging Swallowing Screen
Measured: Within 15 days after diagnosis and 6 months after diagnosis
Secondary outcomes (3)
Change of aphasia disorder
Questionnaire : Aphasia rapid test
Measured: Within 15 days after diagnosis and 6 months after diagnosis
Change of state of depression and anxiety
Questionnaire : anxiety and depression scale
Measured: Within 15 days after diagnosis and 6 months after diagnosis
Change of behavioural attention
Questionnaire : Catherine Bergego scale
Measured: Within 15 days after diagnosis and 6 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, University Hospital, Caen, University Hospital, Montpellier, Centre Hospitalier du Pays d'Aix, Université Joseph Fourier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974530
- Sponsor's protocol ID
- 2016-A00070-51
- Acronym
- AVC-MODE
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description and Modeling of Swallowing Disorders After a Stroke
- ClinicalTrials.gov ID
- NCT02974530
- Acronym / sponsor ID
- AVC-MODE / 2016-A00070-51
- Conditions
- Stroke, Swallowing Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- National Research Agency, France, University Hospital, Caen, University Hospital, Montpellier, Centre Hospitalier du Pays d'Aix, Université Joseph Fourier
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke population | – | Other: Neurological evaluation, Other: Laryngological evaluation, Other: MRI evaluation, Other: Breathing investigation, Other: Postural investigation, Other: Voice and soundscape investigationPatient with stroke will be explored during their acute phase and in 6 months of diagnosis. |
| Healthy population | – | Other: Breathing investigation, Other: MRI and articulatory investigation, Other: Postural investigation, Other: Voice and soundscape investigationHealthy subjects will be explored in Grenoble in research laboratory |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Change of Clinical severity score
Time frame: At inclusion and 6 months after diagnosis
NIHSS scale
Change of swallowing disorder
Time frame: Within 15 days after diagnosis and 6 months after diagnosis
Test : GUgging Swallowing Screen
3 secondary outcomes
Change of aphasia disorder
Time frame: Within 15 days after diagnosis and 6 months after diagnosis
Change of state of depression and anxiety
Time frame: Within 15 days after diagnosis and 6 months after diagnosis
Change of behavioural attention
Time frame: Within 15 days after diagnosis and 6 months after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Hommel, MD contact
Philippe Cousin contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Swallowing Disorders, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Hommel, MD (mhommel@ujf-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clinical severity score (time frame: At inclusion and 6 months after diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.