Facial PalsyNCT03006783
Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis
An observational study of Facial Palsy, run by University Medical Center Groningen.
Trial summary
A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years. Imagery analysis Questionnaires Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Palsy
- What is being tested?
- Cross-face nerve graft
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective cohort of people treated with a cross-face nerve graft or other nerve transfer
Who may be able to join
- Treated with one of the described procedures
Who cannot join
- Evaluation material present
About this study
A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years.
- Imagery analysis
- Questionnaires
Read the detailed description
The investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.
- Conditions
- Facial Palsy
- Being tested
- Cross-face nerve graft
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-face nerve graftProcedure or surgery
connecting the healthy facial nerve to the affected facial nerve
| Study group | Role | What they receive |
|---|---|---|
| Cross-face nerve graft treated | People treated by a solitary cross-face nerve graft or in combination with another procedure. Receives: Procedure: Cross-face nerve graft | |
| Hypoglossal-facial treated | People treated with a solitary hypoglossal-facial anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symmetry of the mouth
Symmetry of the mouth expressed as the difference in millimeters between the position of the affected and the healthy corner of the mouth on a picture. An ideal symmetry would be 0 mm. Measured with the FACE-gram software.
Measured: March 2016 - October 2016
Excursion of the mouth
Excursion of the mouth expressed as the difference in millimeters between the position of the affected corner of the mouth in repose and with smile on a picture. Measured with the FACE-gram software.
Measured: March 2016 - October 2016
Disease-specific quality-of-life
A validated self-reported disease-specific quality-of-life questionnaire was used (Facial Clinimetric Evaluation scale). On which patients can score anything between 0 and 100 points (100 being healty).
Measured: March 2016 - October 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tijn van Veen, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006783
- Sponsor's protocol ID
- TvanVeen
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis
- ClinicalTrials.gov ID
- NCT03006783
- Acronym / sponsor ID
- TvanVeen
- Conditions
- Facial Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years.
- Imagery analysis
- Questionnaires
Detailed description
The investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-face nerve graft treated | – | Procedure: Cross-face nerve graftPeople treated by a solitary cross-face nerve graft or in combination with another procedure. |
| Hypoglossal-facial treated | – | –People treated with a solitary hypoglossal-facial anastomosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective cohort of people treated with a cross-face nerve graft or other nerve transfer
Key inclusion criteria (1 listed)
- Treated with one of the described procedures
Key exclusion criteria (1 listed)
- Evaluation material present
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 |
|---|---|---|
| Cross-face nerve graftconnecting the healthy facial nerve to the affected facial nerve | Procedure or surgery | Cross-face nerve graft treated |
Primary outcome
Symmetry of the mouth
Time frame: March 2016 - October 2016
Symmetry of the mouth expressed as the difference in millimeters between the position of the affected and the healthy corner of the mouth on a picture. An ideal symmetry would be 0 mm. Measured with the FACE-gram software.
Excursion of the mouth
Time frame: March 2016 - October 2016
Excursion of the mouth expressed as the difference in millimeters between the position of the affected corner of the mouth in repose and with smile on a picture. Measured with the FACE-gram software.
Disease-specific quality-of-life
Time frame: March 2016 - October 2016
A validated self-reported disease-specific quality-of-life questionnaire was used (Facial Clinimetric Evaluation scale). On which patients can score anything between 0 and 100 points (100 being healty).
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 30 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Palsy, run by University Medical Center Groningen.
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 1 inclusion and 1 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Symmetry of the mouth (time frame: March 2016 - October 2016). The study lists 3 primary outcomes in all. 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 30 Dec 2016.