Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty (FacialReinn)

May 24, 2016 updated by: University Hospital, Caen

Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators want to study the physiology of nerve healing after lengthening temporalis myoplasty done for facial nerve impairment. The investigators already observed few cases of spontaneous neurotization and the investigators want to check the nerve command of the facial muscles. Clinical and photographic evaluations will be performed before and after a facial nerve block using 1% lidocaine.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse-normandie
      • Caen, Basse-normandie, France, 14000
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient who were operated for a facial paralysis by the lengthening temporalis myoplasty procedure in the University Hospital of Caen and who present signs of contraction of the facial muscles on the plasy side after the procedure.

Exclusion Criteria:

  • Patient with contraindications to the injection of lidocaine
  • Patient treated with beta-blocker
  • Patient on anti-coagulants
  • Pathology cause of facial paralysis evolving
  • Pregnant or lactating
  • Patient incapacitated adult
  • Patient undergoing another study at the same time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Neurotized facial muscle patients
injection of 1% lidocaine, 2mL for facial nerve block
Drug: injection of 1% lidocaine, 2mL for facial nerve block
injection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk
Other Names:
  • facial nerve block following the O'Brien modified technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial muscle contraction after nerve block
Time Frame: 30 minutes after lidocaine injection
clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded
30 minutes after lidocaine injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Daniel Labbé, MD, University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (ESTIMATE)

April 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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