Swallowing Disorders in Minimally Consciousness Patients (MCS) (TC-DEG)

February 17, 2026 updated by: University Hospital, Rouen

Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients

This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After inclusion, the patients will underwent a videofluoroscopy and the Wessex Head Injury Matrix.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bois-Guillaume, France
        • Centre les Herbiers
      • Rouen, France
        • UH Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Legal representant signed
  • Aged between 18 and 70 years
  • Having a severe TBI (Glasgow < 8)
  • Without counterindication to underwent a VideoFluoroScopy
  • Could hold a setting position

Exclusion Criteria:

  • Pregnancy ongoing
  • Having a pathologic al examination of IX, X, XII cranial nerve examination
  • Massif faciale fracture
  • Psychiatric illness
  • Medical history of swallowing disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimally consciousness Patient
Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient
Other: videofluoroscopy
Swallowing description in Minimally consciousness Patient
Other: Wessex Head Injury Matrix scale
Wessex Head Injury Matrix scale in Minimally consciousness Patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stages of swallowing disorders
Time Frame: Day 1
swallowing disorder stage is done using videofluoroscopy
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder
Time Frame: Day 1
Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Eric VERIN, Pr, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Actual)

March 16, 2023

Study Completion (Actual)

March 16, 2023

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/0379 HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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