NCT03562104

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

May 25, 2018

Last Update Submit

February 17, 2026

Conditions

Swallowing DisorderTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Stages of swallowing disorders

    swallowing disorder stage is done using videofluoroscopy

    Day 1

Secondary Outcomes (1)

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

    Day 1

Study Arms (1)

Minimally consciousness Patient

EXPERIMENTAL

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

Other: videofluoroscopyOther: Wessex Head Injury Matrix scale

Interventions

videofluoroscopyOTHER

Swallowing description in Minimally consciousness Patient

Minimally consciousness Patient
Wessex Head Injury Matrix scaleOTHER

Wessex Head Injury Matrix scale in Minimally consciousness Patient

Minimally consciousness Patient

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy ongoing
  • Having a pathologic al examination of IX, X, XII cranial nerve examination
  • Massif faciale fracture
  • Psychiatric illness
  • Medical history of swallowing disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre les Herbiers

Bois-Guillaume, France

Location

UH Rouen

Rouen, France

Location

MeSH Terms

Conditions

Deglutition DisordersBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Eric VERIN, Pr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Description of swallowing
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 19, 2018

Study Start

November 30, 2018

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)