Study Results
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Basic Information
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RECRUITING
104 participants
OBSERVATIONAL
2020-07-24
2025-06-30
Brief Summary
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Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested three times during two consecutive days with the SWADOC tool. Statistical analyses will focus on the reliability and validity of the SWADOC tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R)
Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step towards the development of an individualized dysphagia care plan. A validated scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients and to document the evolution of their disorders.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Unresponsive wakefulness syndrome patients (UWS)
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
SWADOC tool
The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.
It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.
FOTT-SAS
Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required
Minimally conscious patients MINUS (MCS-)
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
SWADOC tool
The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.
It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.
FOTT-SAS
Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required
Minimally conscious patients PLUS
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
SWADOC tool
The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.
It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.
FOTT-SAS
Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required
Patients emerging from the minimally conscious state (EMCS)
The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
SWADOC tool
The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.
It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.
FOTT-SAS
Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required
Interventions
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SWADOC tool
The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.
It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.
FOTT-SAS
Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required
Eligibility Criteria
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Inclusion Criteria
* Perfect knowledge of French language before the injury
* Previous event of coma phase caused by a severe acquired brain injury
* Medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress)
* No neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury
* Minimum of 28 days since the acquired brain injury at inclusion
* Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or SECONDs
* Informed consent from legal representative of the patient
* Affiliated patient or beneficiary of a health insurance plan (for French participants only).
18 Years
ALL
No
Sponsors
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Centre du Cerveau², Centre hospitalier universitaire de Liège
UNKNOWN
Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)
UNKNOWN
Cliniques de Soins Spécialisés Valdor-Pèrî
UNKNOWN
Centre Hospitalier Neurologique William Lennox (UCL)
UNKNOWN
Centre Hospitalier Universitaire de Liege
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
Uzès hospital
UNKNOWN
Fontfroide functional re-education centre, Montpellier, France
UNKNOWN
University of Liege
OTHER
Responsible Party
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Olivia Gosseries
Neuropsychologist, PhD, Co-director of the Coma Science Group, Research Associate at FRS-FNRS
Principal Investigators
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Olivia Gosseries, PhD
Role: STUDY_DIRECTOR
University of Liege, Giga Consciousness
Locations
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Centre Hospitalier Neurologique William Lennox (UCL)
Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium
Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz
Fraiture, , Belgium
Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)
Jette, , Belgium
Centre du Cerveau², University Hospital of Liège
Liège, , Belgium
Cliniques de Soins Spécialisés Valdor-Pèrî
Liège, , Belgium
Fontfroide functional re-education centre
Montpellier, , France
CHU Nîmes
Nîmes, , France
Uzès hospital
Uzès, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Melotte E, Maudoux A, Delhalle S, Lagier A, Thibaut A, Aubinet C, Kaux JF, Vanhaudenhuyse A, Ledoux D, Laureys S, Gosseries O. Swallowing in individuals with disorders of consciousness: A cohort study. Ann Phys Rehabil Med. 2021 Jul;64(4):101403. doi: 10.1016/j.rehab.2020.04.008. Epub 2020 Jul 18.
Sanz LRD, Aubinet C, Cassol H, Bodart O, Wannez S, Bonin EAC, Barra A, Lejeune N, Martial C, Chatelle C, Ledoux D, Laureys S, Thibaut A, Gosseries O. SECONDs Administration Guidelines: A Fast Tool to Assess Consciousness in Brain-injured Patients. J Vis Exp. 2021 Feb 6;(168). doi: 10.3791/61968.
Mortensen J, Jensen D, Kjaersgaard A. A validation study of the Facial-Oral Tract Therapy Swallowing Assessment of Saliva. Clin Rehabil. 2016 Apr;30(4):410-5. doi: 10.1177/0269215515584381. Epub 2015 Apr 28.
Bicego A, Lejoly K, Maudoux A, Lefebvre P, Laureys S, Schweizer V, Diserens K, Faymonville ME, Vanhaudenhuyse A. [Swallowing in disorders of consciousness]. Rev Neurol (Paris). 2014 Oct;170(10):630-41. doi: 10.1016/j.neurol.2014.04.004. Epub 2014 Jun 18. French.
Wannez S, Gosseries O, Azzolini D, Martial C, Cassol H, Aubinet C, Annen J, Martens G, Bodart O, Heine L, Charland-Verville V, Thibaut A, Chatelle C, Vanhaudenhuyse A, Demertzi A, Schnakers C, Donneau AF, Laureys S. Prevalence of coma-recovery scale-revised signs of consciousness in patients in minimally conscious state. Neuropsychol Rehabil. 2018 Dec;28(8):1350-1359. doi: 10.1080/09602011.2017.1310656. Epub 2017 Apr 11.
Melotte E, Belorgeot M, Herr R, Simon J, Kaux JF, Laureys S, Sanz LRD, Lagier A, Morsomme D, Pellas F, Gosseries O. The Development and Validation of the SWADOC: A Study Protocol for a Multicenter Prospective Cohort Study. Front Neurol. 2021 Apr 29;12:662634. doi: 10.3389/fneur.2021.662634. eCollection 2021.
Other Identifiers
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2020_79
Identifier Type: -
Identifier Source: org_study_id
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