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Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty (FacialReinn)

This study has been terminated.
(The study reach enough significance at the intermediary analysis)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01833221
First received: April 12, 2013
Last updated: May 24, 2016
Last verified: April 2014
  Purpose
The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

Condition Intervention Phase
Facial Paresis
Drug: injection of 1% lidocaine, 2mL for facial nerve block
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Facial muscle contraction after nerve block [ Time Frame: 30 minutes after lidocaine injection ] [ Designated as safety issue: No ]
    clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded


Enrollment: 10
Study Start Date: April 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: facial nerve block following the O'Brien modified technique

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.
  Eligibility

Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833221

Locations
France
Centre Hospitalier Universitaire
Caen, Basse-normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Daniel Labbé, MD University Hospital, Caen
  More Information

Publications:
Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01833221     History of Changes
Other Study ID Numbers: 10-159 
Study First Received: April 12, 2013
Last Updated: May 24, 2016
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Direction Générale de la Santé

Keywords provided by University Hospital, Caen:
facial palsy
lengthening temporalis myoplasty
neurotization of facial muscles

Additional relevant MeSH terms:
Facial Paralysis
Paralysis
Facies
Paresis
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016