Swallowing Disorders in Minimally Consciousness Patients (MCS)

NCT ID: NCT03562104

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-06-01

Brief Summary

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

Detailed Description

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

Conditions

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Swallowing Disorder Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Description of swallowing
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Minimally consciousness Patient

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

Group Type EXPERIMENTAL

videofluoroscopy

Intervention Type OTHER

Swallowing description in Minimally consciousness Patient

Wessex Head Injury Matrix scale

Intervention Type OTHER

Wessex Head Injury Matrix scale in Minimally consciousness Patient

Interventions

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videofluoroscopy

Swallowing description in Minimally consciousness Patient

Intervention Type OTHER

Wessex Head Injury Matrix scale

Wessex Head Injury Matrix scale in Minimally consciousness Patient

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric VERIN, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Centre les Herbiers

Bois-Guillaume, , France

Site Status

UH Rouen

Rouen, , France

Site Status

Countries

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France

Central Contacts

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Eric VERIN, Pr

Role: CONTACT

+3323288 ext. 8265

Julien BLOT

Role: CONTACT

+3323288 ext. 8265

Other Identifiers

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2016/379 HP

Identifier Type: -

Identifier Source: org_study_id

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