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Completed

NCT Number: NCT03562104

Swallowing Disorders in Minimally Consciousness Patients (MCS)

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

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Key information

Conditions

Swallowing Disorder Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre les Herbiers, Bois-Guillaume, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

videofluoroscopy

Other

Swallowing description in Minimally consciousness Patient

Wessex Head Injury Matrix scale

Other

Wessex Head Injury Matrix scale in Minimally consciousness Patient

Primary outcomes

  1. Stages of swallowing disorders

    Time frame: Day 1

    swallowing disorder stage is done using videofluoroscopy

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients

Acronym: TC-DEG

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 19, 2018
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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