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NCT03562104 Clinical Trial

Swallowing Disorders in Minimally Consciousness Patients (MCS)

Traumatic Brain Injury Clinical Trial

— TC-DEG  

Official title:
Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03562104
Other study ID # 2016/379 HP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date June 1, 2019

Study information
Verified date June 2018
Source University Hospital, Rouen
Contact Eric VERIN, Pr
Phone +3323288
Email eric.verin@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• videofluoroscopy
Swallowing description in Minimally consciousness Patient
• Wessex Head Injury Matrix scale
Wessex Head Injury Matrix scale in Minimally consciousness Patient

Locations
Country Name City State
France Centre les Herbiers Bois-Guillaume
France UH Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stages of swallowing disorders swallowing disorder stage is done using videofluoroscopy Day 1
Secondary Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy) Day 1
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