Swallowing Disorders in Minimally Consciousness Patients (MCS)

Not Applicable

• Conditions: Swallowing Disorder; Traumatic Brain Injury
• Interventions: Other: videofluoroscopy; Other: Wessex Head Injury Matrix scale

• Registration Number: NCT03562104
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-05-25
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-07
• Last Update Submitted: 2018-06-07
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-19
• Study Start: 2018-09-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally consciousness Patient	Wessex Head Injury Matrix scale	Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient
Minimally consciousness Patient	videofluoroscopy	Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient

Primary Outcome Measures

Name	Time	Method
Stages of swallowing disorders	Day 1	swallowing disorder stage is done using videofluoroscopy

Secondary Outcome Measures

Name	Time	Method
Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder	Day 1	Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy)

Trial Locations

Locations (2)

Centre les Herbiers; 🇫🇷 Bois-Guillaume, France

UH Rouen; 🇫🇷 Rouen, France