Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis

Facial Palsy Clinical Trial

Official title:

Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006783
• Other study ID #: TvanVeen
• Status: Completed
• Phase: N/A
• First received: December 22, 2016
• Last updated: December 28, 2016
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treated with one of the described procedures

Exclusion Criteria:

• Evaluation material present

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bell Palsy
• Facial Palsy
• Facial Paralysis
• Facies
• Paralysis

Intervention

Procedure:
• Cross-face nerve graft
connecting the healthy facial nerve to the affected facial nerve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No