Status:

RECRUITING

Development and Validation of the SWADOC Tool

Lead Sponsor:

University of Liege

Collaborating Sponsors:

Centre du Cerveau², Centre hospitalier universitaire de Liège

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

Conditions:

Swallowing Disorders

Dysphagia

Eligibility:

All Genders

18+ years

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 an...

Eligibility Criteria

Inclusion

  • Inclusion Criteria :
  • 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
  • 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).

Exclusion

    Key Trial Info

    Start Date :

    July 24 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2025

    Estimated Enrollment :

    104 Patients enrolled

    Trial Details

    Trial ID

    NCT04706689

    Start Date

    July 24 2020

    End Date

    June 30 2025

    Last Update

    February 22 2024

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Centre Hospitalier Neurologique William Lennox (UCL)

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

    2

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

    Fraiture, Belgium, 4557

    3

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

    Jette, Belgium

    4

    Centre du Cerveau², University Hospital of Liège

    Liège, Belgium, 4000