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
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
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
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
background
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
background
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
background
Learn more about this trial
Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
We'll reach out to this number within 24 hrs