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Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty (FacialReinn)

Primary Purpose

Facial Paresis

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
injection of 1% lidocaine, 2mL for facial nerve block
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Facial Paresis focused on measuring facial palsy, lengthening temporalis myoplasty, neurotization of facial muscles

Eligibility Criteria

6 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurotized facial muscle patients

Arm Description

injection of 1% lidocaine, 2mL for facial nerve block

Outcomes

Primary Outcome Measures

Facial muscle contraction after nerve block
clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded

Secondary Outcome Measures

Full Information

First Posted
April 12, 2013
Last Updated
May 24, 2016
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT01833221
Brief Title
Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
Acronym
FacialReinn
Official Title
Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
The study reach enough significance at the intermediary analysis
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paresis
Keywords
facial palsy, lengthening temporalis myoplasty, neurotization of facial muscles

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurotized facial muscle patients
Arm Type
Experimental
Arm Description
injection of 1% lidocaine, 2mL for facial nerve block
Intervention Type
Drug
Intervention Name(s)
injection of 1% lidocaine, 2mL for facial nerve block
Other Intervention Name(s)
facial nerve block following the O'Brien modified technique
Intervention Description
injection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk
Primary Outcome Measure Information:
Title
Facial muscle contraction after nerve block
Description
clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded
Time Frame
30 minutes after lidocaine injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Labbé, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Caen
State/Province
Basse-normandie
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
9302902
Citation
Cheney ML, McKenna MJ, Megerian CA, West C, Elahi MM. Trigeminal neo-neurotization of the paralyzed face. Ann Otol Rhinol Laryngol. 1997 Sep;106(9):733-8. doi: 10.1177/000348949710600903.
Results Reference
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PubMed Identifier
9381330
Citation
Fournier HD, Denis F, Papon X, Hentati N, Mercier P. An anatomical study of the motor distribution of the mandibular nerve for a masseteric-facial anastomosis to restore facial function. Surg Radiol Anat. 1997;19(4):241-4. doi: 10.1007/BF01627866.
Results Reference
background
PubMed Identifier
16163078
Citation
Godwin Y, Tomat L, Manktelow R. The use of local anesthetic motor block to demonstrate the potential outcome of depressor labii inferioris resection in patients with facial paralysis. Plast Reconstr Surg. 2005 Sep 15;116(4):957-61. doi: 10.1097/01.prs.0000178043.15510.75.
Results Reference
background
PubMed Identifier
17600609
Citation
Guerreschi P, Labbe D, Carluer L, Drillet C, Benateau H. [Manktelow's test for the use of botulic toxin]. Ann Chir Plast Esthet. 2008 Feb;53(1):59-62. doi: 10.1016/j.anplas.2007.04.010. Epub 2007 Jun 27. French.
Results Reference
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PubMed Identifier
10744217
Citation
Labbe D, Huault M. Lengthening temporalis myoplasty and lip reanimation. Plast Reconstr Surg. 2000 Apr;105(4):1289-97; discussion 1298.
Results Reference
background
PubMed Identifier
15861049
Citation
Lifchez SD, Matloub HS, Gosain AK. Cortical adaptation to restoration of smiling after free muscle transfer innervated by the nerve to the masseter. Plast Reconstr Surg. 2005 May;115(6):1472-9; discussion 1480-2. doi: 10.1097/01.prs.0000160266.81504.71.
Results Reference
background
PubMed Identifier
10709171
Citation
Petropoulos AE, Cheney ML. Induction of facial muscle neurotization by temporalis muscle transposition: literature review and animal model evaluation using horseradish peroxidase uptake. J Otolaryngol. 2000 Feb;29(1):40-6.
Results Reference
background
PubMed Identifier
7696239
Citation
Schimek F, Fahle M. Techniques of facial nerve block. Br J Ophthalmol. 1995 Feb;79(2):166-73. doi: 10.1136/bjo.79.2.166.
Results Reference
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Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

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