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Search / Trial NCT04706689

Development and Validation of the SWADOC Tool

Launched by UNIVERSITY OF LIEGE · Jan 10, 2021

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Swallowing Dysphagia Disorders Of Consciousness Severe Brain Injury

ClinConnect Summary

This clinical trial is studying a new tool called SWADOC, designed to help assess swallowing difficulties in patients who have had severe brain injuries and may be in a state of altered consciousness. Many of these patients experience challenges with swallowing (a condition known as dysphagia), which can lead to serious health issues. The goal of the trial is to develop and validate this tool so that therapists can better understand and track swallowing abilities in these patients, ultimately leading to more personalized care plans.

To participate in this study, individuals must be over 18 years old, have previously been in a coma due to a severe brain injury, and be able to speak French. Participants need to be medically stable, meaning they are not on breathing machines or receiving heavy sedation, and they must have been diagnosed with specific levels of consciousness. Throughout the study, participants will be assessed multiple times to evaluate how well the SWADOC tool works. This research is important as it aims to improve the quality of care for individuals with swallowing disorders following brain injuries.

Gender

ALL

Eligibility criteria

  • 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).

About University Of Liege

The University of Liège, a prestigious research institution in Belgium, is committed to advancing medical science through innovative clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive expertise in various fields, including medicine, pharmacology, and biomedical engineering, to conduct high-quality research aimed at improving patient outcomes. The institution fosters a rigorous ethical framework and adheres to international standards in clinical research, ensuring the integrity and reliability of its studies. Through its clinical trials, the University of Liège aims to contribute significantly to the development of novel therapeutic approaches and enhance the understanding of complex health issues.

Locations

Nîmes, France

Ottignies Louvain La Neuve, Brabant Wallon, Belgium

Fraiture, Belgium

Jette, Belgium

Liège, Belgium

Liège, Belgium

Montpellier, France

Uzès, France

Patients applied

0 patients applied

Trial Officials

Olivia Gosseries, PhD

Study Director

University of Liege, Giga Consciousness

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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