NCT04706689

Brief Summary

Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC tool has been developed to help therapists to apprehend components related to swallowing in patients with DOC. The second aim is to appreciate the relationship between patients' level of consciousness and SWADOC items and scores. 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

4.4 years

First QC Date

January 7, 2021

Last Update Submit

February 21, 2024

Conditions

Swallowing DisordersDysphagiaDisorders of ConsciousnessAssessment ToolSpeech Therapy

Keywords

swallowingdysphagiadisorders of consciousnesssevere brain injury

Outcome Measures

Primary Outcomes (2)

  • Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability

    The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24). The better the score is, the better the swallowing is.

    15-25 minutes (3 times in 5 business days)

  • SECONDs

    The Simplified Evaluation of CONsciousness Disorders (SECONDs): it features a shorter administration time (median of 7 minutes) and required only a mirror as material. It consists of 8 items: observation and reporting spontaneous behaviors, response to command, communication, visual pursuit and fixation, pain localization, oriented behaviors and arousal. The SECONDs provides a total score directly reflecting one diagnosis (0 = coma, 1 = UWS, 2-5 = MCS-, 6-7 = MCS+, 8 = EMCS). The better the score is, the better the consciousness level is.

    7 minutes (immediately before or after the SWADOC tool in each of the three sessions)

Secondary Outcomes (2)

  • SWADOC-scored by Examiner 2 (inter-reliability)

    15-25 minutes - immediately before or after one of the three sessions

  • FOTT-SAS (Examiner 1)

    Immediately after one of the three sessions

Study Arms (4)

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).

Behavioral: SWADOC toolBehavioral: FOTT-SAS

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).

Behavioral: SWADOC toolBehavioral: FOTT-SAS

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).

Behavioral: SWADOC toolBehavioral: FOTT-SAS

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).

Behavioral: SWADOC toolBehavioral: FOTT-SAS

Interventions

SWADOC toolBEHAVIORAL

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.

Minimally conscious patients MINUS (MCS-)Minimally conscious patients PLUSPatients emerging from the minimally conscious state (EMCS)Unresponsive wakefulness syndrome patients (UWS)
FOTT-SASBEHAVIORAL

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-)Minimally conscious patients PLUSPatients emerging from the minimally conscious state (EMCS)Unresponsive wakefulness syndrome patients (UWS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be carried out in patients with DOC or emerging from DOC following severe acquired brain injury. Patients will be divided into four groups according to their clinical diagnosis assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs): UWS, MCS-, MCS+ and EMCS. Participants will be recruited from inpatient neurological rehabilitation programs in post-coma units and rehabilitation services, or hospitalized for an evaluation of multimodal assessment of consciousness for diagnostic and prognostic purposes. We will include 26 patients in each group, which will result in a total of 104 patients.

You may qualify if:

  • Age above 18-year-old
  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Centre Hospitalier Neurologique William Lennox (UCL)

Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340, Belgium

RECRUITING

Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz

Fraiture, 4557, Belgium

RECRUITING

Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)

Jette, Belgium

RECRUITING

Centre du Cerveau², University Hospital of Liège

Liège, 4000, Belgium

RECRUITING

Cliniques de Soins Spécialisés Valdor-Pèrî

Liège, 4000, Belgium

RECRUITING

Fontfroide functional re-education centre

Montpellier, France

RECRUITING

CHU Nîmes

Nîmes, France

NOT YET RECRUITING

Uzès hospital

Uzès, France

NOT YET RECRUITING

Related Publications (6)

  • 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.

    PMID: 32535170BACKGROUND

  • 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.

    PMID: 33616111BACKGROUND

  • 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.

    PMID: 25920675BACKGROUND

  • 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.

    PMID: 24952924BACKGROUND

  • 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.

    PMID: 28399715BACKGROUND

  • 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.

    PMID: 33995257DERIVED

MeSH Terms

Conditions

Deglutition DisordersConsciousness DisordersCommunication DisordersBrain Injuries

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersNeurodevelopmental DisordersBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Olivia Gosseries, PhD

    University of Liege, Giga Consciousness

    STUDY DIRECTOR

Central Study Contacts

Evelyne Mélotte, M.D.

CONTACT

00323663915evelyne.melotte@chuliege.be

Marion Belorgeot, M.D.

CONTACT

marion.belorgeot@wanadoo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuropsychologist, PhD, Co-director of the Coma Science Group, Research Associate at FRS-FNRS

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 13, 2021

Study Start

July 24, 2020

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

FR(3)BE(5)