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Trial record 15 of 41 for:    Bell's Palsy

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

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ClinicalTrials.gov Identifier: NCT03006783
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Information provided by (Responsible Party):
Tijn van Veen, University Medical Center Groningen

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

Condition or disease Intervention/treatment
Facial Palsy Procedure: Cross-face nerve graft

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 Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis
Study Start Date : March 2016
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
connecting the healthy facial nerve to the affected facial nerve
Hypoglossal-facial treated
People treated with a solitary hypoglossal-facial anastomosis.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective cohort of people treated with a cross-face nerve graft or other nerve transfer

Inclusion Criteria:

  • Treated with one of the described procedures

Exclusion Criteria:

  • Evaluation material present

Responsible Party: Tijn van Veen, M.M. van Veen, BSc, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03006783     History of Changes
Other Study ID Numbers: TvanVeen
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Facial Paralysis
Bell Palsy
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases