NCT03006783

Brief 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 22, 2016

Last Update Submit

December 28, 2016

Conditions

Facial Palsy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    March 2016 - October 2016

Study Arms (2)

Cross-face nerve graft treated

People treated by a solitary cross-face nerve graft or in combination with another procedure.

Procedure: Cross-face nerve graft

Hypoglossal-facial treated

People treated with a solitary hypoglossal-facial anastomosis.

Interventions

Cross-face nerve graftPROCEDURE

connecting the healthy facial nerve to the affected facial nerve

Cross-face nerve graft treated

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective cohort of people treated with a cross-face nerve graft or other nerve transfer

You may qualify if:

  • Treated with one of the described procedures

You may not qualify if:

  • Evaluation material present

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.M. van Veen, BSc

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 30, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 30, 2016

Record last verified: 2016-12