Swallowing Disorders in Minimally Consciousness Patients (MCS)

Not Applicable

• Conditions: Swallowing Disorder; Traumatic Brain Injury

• 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

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