Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

Facial Paresis Clinical Trial

— FacialReinn  

Official title:

Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01833221
• Other study ID #: 10-159
• Status: Terminated
• Phase: Phase 4
• First received: April 12, 2013
• Last updated: May 24, 2016
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Facial Paresis
• Facies

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Caen	Basse-normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (8)

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. Review. — View 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. — View 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. — View Citation

Guerreschi P, Labbé D, Carluer L, Drillet C, Bénateau H. [Manktelow's test for the use of botulic toxin]. Ann Chir Plast Esthet. 2008 Feb;53(1):59-62. Epub 2007 Jun 27. French. — View Citation

Labbé D, Huault M. Lengthening temporalis myoplasty and lip reanimation. Plast Reconstr Surg. 2000 Apr;105(4):1289-97; discussion 1298. — View 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. — View 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. Review. — View Citation

Schimek F, Fahle M. Techniques of facial nerve block. Br J Ophthalmol. 1995 Feb;79(2):166-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes after lidocaine injection	No