Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

NCT ID: NCT01833221

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Facial Paresis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Neurotized facial muscle patients

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

injection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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facial nerve block following the O'Brien modified technique

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Labbé, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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Centre Hospitalier Universitaire

Caen, Basse-normandie, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 9302902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9381330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16163078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17600609 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10744217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15861049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10709171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7696239 (View on PubMed)

Other Identifiers

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10-159

Identifier Type: -

Identifier Source: org_study_id

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