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

Primary Purpose

Swallowing Disorder, Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
videofluoroscopy
Wessex Head Injury Matrix scale
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Swallowing Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre les Herbiers
  • UH Rouen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally consciousness Patient

Arm Description

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

Outcomes

Primary Outcome Measures

Stages of swallowing disorders
swallowing disorder stage is done using videofluoroscopy

Secondary Outcome Measures

Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder
Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy)

Full Information

First Posted
May 25, 2018
Last Updated
June 7, 2018
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT03562104
Brief Title
Swallowing Disorders in Minimally Consciousness Patients (MCS)
Acronym
TC-DEG
Official Title
Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorder, Traumatic Brain Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Description of swallowing
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimally consciousness Patient
Arm Type
Experimental
Arm Description
Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient
Intervention Type
Other
Intervention Name(s)
videofluoroscopy
Intervention Description
Swallowing description in Minimally consciousness Patient
Intervention Type
Other
Intervention Name(s)
Wessex Head Injury Matrix scale
Intervention Description
Wessex Head Injury Matrix scale in Minimally consciousness Patient
Primary Outcome Measure Information:
Title
Stages of swallowing disorders
Description
swallowing disorder stage is done using videofluoroscopy
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder
Description
Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric VERIN, Pr
Phone
+3323288
Ext
8265
Email
eric.verin@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric VERIN, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre les Herbiers
City
Bois-Guillaume
Country
France
Facility Name
UH Rouen
City
Rouen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Swallowing Disorders in Minimally Consciousness Patients (MCS)

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