Swallowing DisorderTC-DEGNCT03562104
Swallowing Disorders in Minimally Consciousness Patients (MCS)
A study testing videofluoroscopy and Wessex Head Injury Matrix scale in people with Swallowing Disorder and Traumatic Brain Injury, run by University Hospital, Rouen at 2 sites in France.
Trial summary
This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Swallowing Disorder, Traumatic Brain Injury
- What is being tested?
- videofluoroscopy and Wessex Head Injury Matrix scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Nov 2018to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy ongoing
- Having a pathologic al examination of IX, X, XII cranial nerve examination
- Massif faciale fracture
- Psychiatric illness
- Medical history of swallowing disorders
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients
This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.
Read the detailed description
After inclusion, the patients will underwent a videofluoroscopy and the Wessex Head Injury Matrix.
- Conditions
- Swallowing Disorder, Traumatic Brain Injury
- Being tested
- videofluoroscopy, Wessex Head Injury Matrix scale
- Medical subject headings
- Deglutition Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videofluoroscopyOther
Swallowing description in Minimally consciousness Patient
Wessex Head Injury Matrix scaleOther
Wessex Head Injury Matrix scale in Minimally consciousness Patient
| Study group | Role | What they receive |
|---|---|---|
| Minimally consciousness Patient | Experimental | Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient Receives: Other: videofluoroscopy; Other: Wessex Head Injury Matrix scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of swallowing disorders
swallowing disorder stage is done using videofluoroscopy
Measured: Day 1
Secondary outcomes (1)
Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder
Correlation between Wessex Head Injury Matrix (WHIM) and swallowing disorder (Videofluoroscopy)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start30 Nov 2018
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Description of swallowing
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERIN, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562104
- Sponsor's protocol ID
- 2016/0379 HP
- Acronym
- TC-DEG
- Status last verified
- Feb 2026
- First submitted
- 25 May 2018
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT03562104
- Acronym / sponsor ID
- TC-DEG / 2016/0379 HP
- Conditions
- Swallowing Disorder, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Description of swallowing
| Arm | Type | Receives |
|---|---|---|
| Minimally consciousness Patient | Experimental | Other: videofluoroscopy, Other: Wessex Head Injury Matrix scaleWessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy ongoing
- Having a pathologic al examination of IX, X, XII cranial nerve examination
- Massif faciale fracture
- Psychiatric illness
- Medical history of swallowing disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videofluoroscopySwallowing description in Minimally consciousness Patient | Other | Minimally consciousness Patient |
| Wessex Head Injury Matrix scaleWessex Head Injury Matrix scale in Minimally consciousness Patient | Other | Minimally consciousness Patient |
Primary outcome
Stages of swallowing disorders
Time frame: Day 1
swallowing disorder stage is done using videofluoroscopy
1 secondary outcome
Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric VERIN, Pr principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videofluoroscopy and Wessex Head Injury Matrix scale in people with Swallowing Disorder and Traumatic Brain Injury, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stages of swallowing disorders (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.